MicroPort Orthopedics Total Hip Systems MR Labeling

K173898 · Microport Orthopedics Inc. (Mpo) · LZO · Sep 20, 2018 · Orthopedic

Device Facts

• Record ID: K173898
• Device Name: MicroPort Orthopedics Total Hip Systems MR Labeling
• Applicant: Microport Orthopedics Inc. (Mpo)
• Product Code: LZO · Orthopedic
• Decision Date: Sep 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The MicroPort total hip systems devices are single use only devices.

Device Story

Subject devices are passive hip joint replacement prostheses including acetabular shells/liners, femoral heads/stems, modular necks, and fixation components. These are existing, legally marketed implants; the submission introduces updated MR Conditional labeling and symbols. No changes to device design, materials, or manufacturing. Used in orthopedic surgery for total hip arthroplasty. Output is the physical replacement of the hip joint. Benefits include pain relief and restored function. Safety and compatibility in MR environments were validated via bench testing per FDA guidance and ASTM standards.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing regarding MR safety and compatibility.

Technological Characteristics

Passive hip implants manufactured from cobalt-chromium-molybdenum alloy, titanium alloy, unalloyed titanium, alumina ceramic, Alumina Matrix Composite (Biolox Delta), PMMA, and UHMWPE. Conforms to ASTM/ISO standards. No changes to materials or design; update limited to MR Conditional labeling.

Indications for Use

Indicated for total hip arthroplasty in skeletally mature patients for pain relief/improved function due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, hip dysplasia), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, or revision of failed prior treatments.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• CANCELLOUS BONE SCREW (K864626)
• PERFECTA II TOTAL HIP SYSTEM (K883618)
• CERAMIC FEMORAL HEAD (K893685)
• ORTHOMET ACETABULAR CUP SYSTEM (K931333)
• SLT FEMORAL HEAD (K932222)
• ORTHOMET RESURFACING FEMORAL COMPONENT (K944752)
• SLT 28MM XXL FEMORAL HEAD (K953025)
• LINEAGE ACETABULAR SYSTEM (K002149)
• PRO-FEMUR R (K003016)
• PERFECTA AND EXTEND (K004032)
• PRO-FEMUR (K012091)
• STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX (K021346)
• PROCOTYL-E ACETABULAR SYSTEM (K043073)
• PROFEMUR RENAISSANCE HIP STEM (K051995)
• LINEAGE A-CLASS POLY LINER (K052026)
• PROFEMUR XTR HIP STEM (K052915)
• PROFEMUR TL HIP STEM (K060358)
• DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER (K061547)
• GLADIATOR BIPOLAR SYSTEM (K062693)
• CONSERVE FEMORAL RESURFACING COMPONENT (K062960)
• DYNASTY ACETABULAR SYSTEM (K070785)
• DYNASTY CERAMIC FEMORAL HEAD (K072656)
• CONSERVE PRESSFIT FEMORAL COMPONENT (K082673)
• DYNASTY POROUS ACETABULAR SHELL, POLYETHYLENE ACETABULAR LINER, METAL ACETABULAR LINER (K082924)
• PROFEMUR HIP SYSTEM MODULAR NECKS (K091423)
• GLADIATOR PLASMA CLASSIC HIP STEM (K110399)
• PROFEMUR(R) E CEMENTLESS HIP STEM (K111698)
• PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM (K111699)
• GLADIATOR HIP STEM (K111910)
• PRESERVE HIP STEM (K112080)
• PROFEMUR GLADIATOR HA HIP STEM (K112150)
• PROFEMUR Z REVISION HIP STEM (K121221)
• PROFEMUR Z CLASSIC STEMS (K132424)
• PROFEMUR TL CLASSIC HIP STEM (K123688)
• PROFEMUR XM DISTAL CENTRALIZER (K130167)
• DYNASTY ACETABULAR SYSTEM WITH CERAMIC (K130376)
• PROFEMUR RENAISSANCE CLASSIC HIP STEM (K130984)
• DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD (K140043)
• PROFEMUR TL CLASSIC LONG NECK HIP STEMS (K140676)
• PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS (K141235)
• PROCOTYL L-O ACETABULAR SYSTEM (K142119)
• PROFEMUR Preserve Size 1-3 Hip Stems (K150133)
• PROFEMUR Preserve Classic Stem (K150302)
• PROCOTYL PRIME ACETABULAR CUP SYSTEM (K170444)
• PROCOTYL® PRIME E-CLASS™ XLPE Liner (K171181)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 20, 2018

MicroPort Orthopedics Inc. (MPO) % Usman Rashid Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002

## Re: K173898

Trade/Device Name: MicroPort Orthopedics Total Hip Systems MR Labeling Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, JDI, MAY, LPH, MBL, LWJ, KWY, KXA Dated: August 2, 2018 Received: August 13, 2018

## Dear Usman Rashid:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K173898

Device Name See indications for use section.

Indications for Use (Describe)

#### CANCELLOUS BONE SCREW

This cancellous bone screw is indicated for use where screw purchase with cancellous bone is required.

#### PERFECTA II TOTAL HIP SYSTEM

The Perfecta II Hip System is intended application only. The prosthesis system will be used in indications which are the same as indications for other cemented total hip designs such as the Zimmer Harris/Galante, the Biomet Bimetric, the Harris Precoat and the Howmedica Precision Hip System. Some include replacement of the femoral head and acetabular portions of the hip joint due to degenerative bone disease, trauma or complications from failed prostheses.

#### CERAMIC FEMORAL HEAD

The McCutchen Femoral Hip Prothesis is indicated for relief of pain and restoration of hip function in skeletally mature patients with: bicompartmental joint disease secondary to osteoarthritis or traumatic arthritis, avascular necrosis of the femoral head, painful hip dyplasia, acute fracture of the femoral neck, protrusio acetabuli, ankylosis, revision procedures for which an adequate fit may be achieved by the operating surgery. This hip stem prosthesis can be used with all short, medium, and long 28 and 32mm Ceramic Femoral Heads.

#### ORTHOMET ACETABULAR CUP SYSTEM

The intended use for the Orthomet Acetabular Cup System is identical to that of the acetabular cups of the Orthomet PERFECTA Total Hip System. The Orthomet Acetabular Cup is intended for cemented application only. Indications for the Orthomet Acetabular Cup will remain the same as indications for the original acetabular components of the PERFECTA Total Hip system and other acetabular cup systems currently available in commercial distribution, such as the Depuy Solution Acetabular Cup, Intermedics APR Acetabular Cup, Joint Medical Products S-ROM Acetabular Cup, Smith & Nephew Richards opti-Fix Acetabular Cup, and smith & Nephew Richards Reflection Acetabular Cup. Some indications include replacement of the femoral head and acetabular portions of the hip joint due to degenerative bone disease, trauma, or complications from failed prostheses.

#### SLT FEMORAL HEAD

This femoral head can only be used with stems labeled for use with this product, and the stem labeling should be consulted to determine its compatibility with this product. The SLT Femoral Head may be used with appropriately sized polyethylene-lined acetabular cups or bipolar endoprostheses.

#### ORTHOMET RESURFACING FEMORAL COMPONENT

The Orthomet Resurfacing Femoral Component (from this point forward referred to as the Resurfacing Femoral Component) is intended for single use in a cemented application only. The Resurfacing Femoral Component will be used in indications which are the same as indications for other commercially available femoral resurfacing components such as the Endotec Integrated Resurfacing Hip, DePuy Indiana Conservative Hip, DePuy T.A.R.A. Hemi Articular Hip Replacement, and Zimmer THARIES Surface Replacement System. Some indications include resurfacing of the femoral head portion of the hip joint due to avascular necrosis, degenerative bone disease, trauma, or complications from failed prostheses.

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### SLT 28MM XXL FEMORAL HEAD

The SLT 28mm XXL Femoral Head is indicated in total hip arthroplasty for reductionor relief of pain and/or improved hip function in skeletally mature patients with thefollowing conditions:

1) Non-inflammatory degenerative joint disease such as osteoarthritis, avascularnecrosis, ankylosis, protrusio acetabuli. and painful hip dysplasia;

2) Inflammatory degenerative joint disease such as rheumatoid arthritis;

3) Correction of functional deformity;

4) Revision procedures where other treatments or devices have failed; and

5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximalfemur with head involvement that are unmanageable using other techniques.

## LINEAGE ACETABULAR SYSTEM

Indicated for use in total hip atthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2) inflammatory degenerative joint disease such as rheumatoid arthritis;

3) correction of functional deformity;

4) revision procedures where other treatments or devices have failed; and,

5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

#### PRO-FEMUR R

Indicated for use in total hip atthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2) inflammatory degenerative joint disease such as rheumatoid arthritis;

3) correction of functional deformity;

4) revision procedures where other treatments or devices have failed; and,

5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

#### PERFECTA AND EXTEND

Indicated for use in total hip atthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2) inflammatory degenerative joint disease such as rheumatoid arthritis;

3) correction of functional deformity;

4) revision procedures where other treatments or devices have failed; and,

5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

#### PRO-FEMUR

Indicated for use in total hip atthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:

2) inflammatory degenerative joint disease such as rheumatoid arthritis;

3) correction of functional deformity;

4) revision procedures where other treatments or devices have failed; and,

5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

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## STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1) Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:

- 2) Inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3) Correction of functional deformity;
- 4) Revision procedures where other treatments or devices have failed; and,

5) Treatment of fractures that are unmanageable using other techniques.

## PROCOTYL-E ACETABULAR SYSTEM

The PROCOTYL-E Acetabular System is indicated for use in total hip arthroplasty forreduction or relief of pain and/or improved hip function in skeletally mature patients withthe following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascularnecrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity;
- 4. revision procedures where other treatments or devices have failed; and,

5. treatment of fractures that are unmanageable using other techniques.

The PROCOTYL-E Acetabular System consists of single use components that arentended to accommodate for bone loss. This system is to be used in conjunction with associated WMT polyethylene and metal Acetabular liners articulating with associated WMT metal and ceramic femoral heads as part of an uncemented total hip arthroplasty.

#### PROFEMUR RENAISSANCE HIP STEM

The PROFEMUR® RENAISSANCE™ Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,
- 4. revision procedures where other treatments or devices have failed

#### LINEAGE A-CLASS POLY LINER

Indications For Use: The LINEAGE® A-CLASS™ Poly Liner is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,
- 4. revision procedures where other treatments or devices have failed.

#### PROFEMUR XTR HIP STEM

The PROFEMUR® XTR Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and.
- 4. revision procedures where other treatments or devices have failed.

#### PROFEMUR TL HIP STEM

ThePROFEMUR® TL Hip Stem is indicated for use in total hip arthroplasty for reductionor relief of pain and/or improved hip function in skeletally mature patients with thefollowing conditions:

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1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosls, arlkylosis, protrusio acetabuli, and painful hip dysplasia;

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,
- 4. revision procedures where other treatments or devices have failed.

# DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER

The DYNASTY® Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with thefollowing conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosss, arlkylosis, protrusio acetabuli, and painful hip dysplasia;

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,
- 4. revision procedures where other treatments or devices have failed.

#### GLADIATOR BIPOLAR SYSTEM

The GLADIATOR® Bipolar System is indicated for the following conditions:

- 1. pathological fractures of the femoral neck.
- 2. non-union of femoral neck fractures.
- 3. aseptic necrosis of the femoral head and neck.
- 4. primary pathology in the young involving the femoral head but wuth non-deformed acetabulum

## CONSERVE FEMORAL RESURFACING COMPONENT

The CONSERVE® Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature with non- inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis,protrusion acetabuli, and painful hip dysplasia.The CONSERVE® Femoral Resurfacing Component is indicated for cemented use only.

#### DYNASTY ACETABULAR SYSTEM

The DYNASTY™ Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.The DYNASTY™ Acetabular Shell is for both cemented and uncemented use.

#### DYNASTY CERAMIC FEMORAL HEAD

The DYNASTY™ Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,
- 4. revision procedures where other treatments or devices have failed.

The DYNASTYTM Acetabular Shell is for both cemented and uncemented use.

## CONSERVE PRESSFIT FEMORAL COMPONENT

The CONSERVE® Pressfit Femoral Resurfacing Component is indicated for use inhemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia. CONSERVE® Pressfit Femoral Resurfacing Component is intended for non-cemented use.

FORM FDA 3881 (7/17)

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DYNASTY POROUS ACETABULAR SHELL, POLYETHYLENE ACETABULAR LINER, METAL ACETABULAR LINER

The DYNASTY® Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

The size 50 and 54mm ceramic femoral heads are only intended for patients with giganticism or malunion of the acetabulum, and/or revision.

The DYNASTY® Acetabular Shell is for both cemented and uncemented use and is a single use device.

## PROFEMUR HIP SYSTEM MODULAR NECKS

The PROFEMUR® Hip System Modular Necks are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

Modular necks can be used during either cemented or uncemented femoral and acetabular arthroplasty.

## GLADIATOR PLASMA CLASSIC HIP STEM

The GLADIATOR® Plasma Classic Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

The GLADIATOR® Plasma Classic Hip Stem are intended for use during uncemented hip arthroplasty

## PROFEMUR(R) E CEMENTLESS HIP STEM

The PROFEMUR® E Cementless Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/ or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

The PROFEMUR® E Cementless Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.

#### PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM

The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

- 3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed.

The PROFEMUR® Z Titanium Plasma Sprayed Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.

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## GLADIATOR HIP STEM

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed. The Gladiator cpTi Plasma Sprayed hip stem is intended for cementless hip arthroplasty.

The Gladiator Cemented hip stem is intended for cemented hip arthroplasty.

#### PRESERVE HIP STEM

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli. and painful hip dysplasia;

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed. The Preserve hip stem is intended for cementless hip arthroplasty.

## PROFEMUR GLADIATOR HA HIP STEM

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli. and painful hip dysplasia;

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,
- 4. revision procedures where other treatments or devices have failed.

The PROFEMUR® Gladiator HA Hip Stem is intended for cementless hip arthroplasty.

## PROFEMUR Z REVISION HIP STEM

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascularnecrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,
- 4. revision procedures where other treatments or devices have failed.

The PROFEMUR® Z Revision Hip Stem is intended for cementless hip arthroplasty.

#### PROFEMUR Z CLASSIC STEMS

The PROFEMUR® Z Classic Stems are in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,
- 4. revision procedures where other treatments or devices have failed.

The PROFEMUR® Z Classic Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

#### PROFEMUR TL CLASSIC HIP STEM

The PROFEMUR® TL Classic Stems are indicated for use in total hip arthroplasty forreduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascularnecrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,
- 4. revision procedures where other treatments or devices have failed.

The PROFEMUR® TL Classic Stems are single use components, intended for use inconjunction with associated ceramic

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or metal femoral heads as part of uncemented total hip arthroplasty.

# PROFEMUR XM DISTAL CENTRALIZER

The PMMA Distal Centralizers are in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and.

4. revision procedures where other treatments or devices have failed.

The PMMA Distal Centralizers are single use components, intended for use as part of a cemented total hip arthroplasty.

## DYNASTY ACETABULAR SYSTEM WITH CERAMIC

Wright Medical total hip systems are in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,
- 4. revision procedures where other treatments or devices have failed

## PROFEMUR RENAISSANCE CLASSIC HIP STEM

The PROFEMUR® RENAISSANCE® Classic Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

The PROFEMUR® RENAISSANCE® Classic Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD The DYNASTY® Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failedShells with BIOFOAM metal foam coating are intended only for uncemented arthroplasty. Modular shells with porous metal bead in either cemented or uncemented arthroplasty.

## PROFEMUR TL CLASSIC LONG NECK HIP STEMS

The PROFEMUR® TL Classic Long Neck Hip Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

The PROFEMUR® TL Classic Long Neck Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

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## PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS

The PROFEMUR® RENAISSANCE® Classic Long Neck Hip Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli. and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

- 3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed.

The PROFEMUR® RENAISSANCE® Classic Long Neck Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

## PROCOTYL L-O ACETABULAR SYSTEM

The PROCOTYL® L-O Acetabular System is intedned for use in total hip arthroplasty for reduction or relief of pain and/ or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

The PROCOTYL® L-O Acetabular System utilizes single use components, intended for use in conjunction with associated ceramic femoral heads as part of uncemented total hip arthroplasty.

#### PROFEMUR Preserve Size 1-3 Hip Stems

The PROFEMUR® Preserve Sizes 1-3 Hip Stems are intedned for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and.

4. revision procedures where other treatments or devices have failed.

The PROFEMUR® Preserve Sizes 1-3 Hip Stems are single use components, intended for use in conjunction with associated ceramic femoral heads as part of uncemented total hip arthroplasty.

#### PROFEMUR Preserve Classic Stem

The PROFEMUR® Preserve Classic Stems are intedned for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

The PROFEMUR® Preserve Classic Stems are single use components, intended for use in conjunction with associated ceramic femoral heads as part of uncemented total hip arthroplasty.

#### PROCOTYL PRIME ACETABULAR CUP SYSTEM

The PROCOTYL® PRIME Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief ofpain and/or improved hip function in skeletally mature patients with the following conditions:

1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli,and painful hip dysplasia;

2) inflammatory degenerative joint disease such as rheumatoid arthritis;

- 3) correction of functional deformity; and,
4) revision procedures where other treatments or devices have failed.

Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

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## PROCOTYL® PRIME E-CLASS™ XLPE Liner

The PROCOTYL® PRIME E-CLASS™ XLPE Liner is intended for use in total hiparthroplasty for reduction or relief of pain and/or improved hip function in skeletallymature patients. This device is indicated for the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascularnecrosis, ankyloses, protrusion acetabuli, and painful hip dysplasia;

2) inflammatory degenerative joint disease such as rheumatoid arthritis;

3) correction of functional deformity; and,

4) revision procedures where other treatments or devices have failed.

Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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Image /page/11/Picture/1 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a white circle containing a red star. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red below it. The text "MicroPort Orthopedics Inc." is below the logo in black.

## 510(k) Summary

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the MicroPort Orthopedics' (MPO) hip systems in an MRI environment.

| Submitted by: | MicroPort Orthopedics Inc.<br>5677 Airline Rd<br>Arlington, TN 38002<br>Phone: [phone]<br>Fax: [phone] |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 19th, 2018 |
| Contact Person: | Usman Rashid<br>Regulatory Affairs Specialist II |
| Proprietary Name of Modified Device: | MicroPort Orthopedics Inc. Hip Systems<br>MR Labeling |
| Common Name: | MPO Total Hip System - Femoral Hip Stem,<br>Femoral Head, Acetabular Shell, Acetabular<br>Liner |
| Classification Name and Reference: | 888.3353 LZO<br>Hip joint metal/ceramic/polymer semi<br>constrained cemented or nonporous,<br>uncemented prosthesis<br>Class II |
| | 888.3350 JDI<br>Hip joint metal/polymer semi-constrained<br>cemented prosthesis<br>Class II |
| | 888.3353 MAY<br>Hip joint metal/ceramic/polymer semi-<br>constrained cemented or nonporous<br>uncemented prosthesis<br>Class II |

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Image /page/12/Picture/1 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a white circle containing a red diamond shape. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" underneath in red. Below the logo is the text "MicroPort Orthopedics Inc." in black.

## Classification Name and Reference (cont):

888.3358 LPH Hip joint metal/polymer/metal semi-Constrained porous-coated uncemented prosthesis Class II

888.3358 MBL Hip joint metal/polymer/metal semi-Constrained poruous-coated uncemented prosthesis Class II

888.3360 LWJ Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Class II

888.3390 KWY Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Class II

888.3400 KXA Hip joint femoral (hemi-hip) metallic resurfacing prosthesis Class II

## Subject Product Code and Panel Code:

Orthopedics/87/LZO/JDI/MAY/LPH/MBL/LWJ/KWY/KXA

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Image /page/13/Picture/1 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with a red star-like shape inside on the left. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red below it. The text "MicroPort Orthopedics Inc." is below the logo in black.

MPO Hip Systems MR Labeling
510(k) Summary

# Predicate Devices:

Table 1: Predicate Table with Submission Numbers and Descriptions

| Submission<br>Number | Description |
|----------------------|----------------------------------------------------------------------------------------|
| K864626 | CANCELLOUS BONE SCREW |
| K883618 | PERFECTA II TOTAL HIP SYSTEM |
| K893685 | CERAMIC FEMORAL HEAD |
| K931333 | ORTHOMET ACETABULAR CUP SYSTEM |
| K932222 | SLT FEMORAL HEAD |
| K944752 | ORTHOMET RESURFACING FEMORAL COMPONENT |
| K953025 | SLT 28MM XXL FEMORAL HEAD |
| K002149 | LINEAGE ACETABULAR SYSTEM |
| K003016 | PRO-FEMUR R |
| K004032 | PERFECTA AND EXTEND |
| K012091 | PRO-FEMUR |
| K021346 | STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX |
| K043073 | PROCOTYL-E ACETABULAR SYSTEM |
| K051995 | PROFEMUR RENAISSANCE HIP STEM |
| K052026 | LINEAGE A-CLASS POLY LINER |
| K052915 | PROFEMUR XTR HIP STEM |
| K060358 | PROFEMUR TL HIP STEM |
| K061547 | DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER |
| K062693 | GLADIATOR BIPOLAR SYSTEM |
| K062960 | CONSERVE FEMORAL RESURFACING COMPONENT |
| K070785 | DYNASTY ACETABULAR SYSTEM |
| K072656 | DYNASTY CERAMIC FEMORAL HEAD |
| K082673 | CONSERVE PRESSFIT FEMORAL COMPONENT |
| K082924 | DYNASTY POROUS ACETABULAR SHELL, POLYETHYLENE ACETABULAR LINER, METAL ACETABULAR LINER |
| K091423 | PROFEMUR HIP SYSTEM MODULAR NECKS |
| K110399 | GLADIATOR PLASMA CLASSIC HIP STEM |
| K111698 | PROFEMUR(R) E CEMENTLESS HIP STEM |
| K111699 | PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM |
| K111910 | GLADIATOR HIP STEM |
| K112080 | PRESERVE HIP STEM |
| K112150 | PROFEMUR GLADIATOR HA HIP STEM |
| K121221 | PROFEMUR Z REVISION HIP STEM |
| K132424 | PROFEMUR Z CLASSIC STEMS |
| Submission<br>Number | Description |
| K123688 | PROFEMUR TL CLASSIC HIP STEM |
| K130167 | PROFEMUR XM DISTAL CENTRALIZER |
| K130376 | DYNASTY ACETABULAR SYSTEM WITH CERAMIC |
| K130984 | PROFEMUR RENAISSANCE CLASSIC HIP STEM |
| K140043 | DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD |
| K140676 | PROFEMUR TL CLASSIC LONG NECK HIP STEMS |
| K141235 | PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS |
| K142119 | PROCOTYL L-O ACETABULAR SYSTEM |
| K150133 | PROFEMUR Preserve Size 1-3 Hip Stems |
| K150302 | PROFEMUR Preserve Classic Stem |
| K170444 | PROCOTYL PRIME ACETABULAR CUP SYSTEM |
| K171181 | PROCOTYL® PRIME E-CLASS™ XLPE Liner |

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Image /page/14/Picture/1 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red diamond shape. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red underneath. Below the logo is the text "MicroPort Orthopedics Inc." in a smaller, darker font.

Table 1: Predicate Table with Submission Numbers and Descriptions (cont.)

## Device Description

The only changes to the subject hip systems are updates to the labeling of the devices. Specifically, the package inserts and package labels are being updated to include MR Conditional language and symbols. The subjects are identical to the predicates in all aspects except for the labeling updates. Testing is provided in this Traditional 510(k) that establishes the safety and compatibility of the passive implants in a magnetic resonance (MR) environment.

The subject devices are a variety of hip joint replacement prostheses. The components for these systems include an acetabular shell, acetabular liner, fixation screws, femoral head, femoral stem, modular neck, proximal body, centralizers, bone plugs, and neck sleeves. These components can be utilized in a variety of configurations to assemble the final construct.

The femoral and acetabular components are manufactured from a variety of materials which include cobalt-chromium-molybdenum alloy, titanium alloy, unalloyed titanium, alumina ceramic, Alumina Matrix Composite ceramic (Biolox Delta), polymethylmethacrylate (PMMA), and ultra high molecular weight polyethylene (UHMWPE), all of which conform to ASTM or ISO standards, or internal standards.

## Intended Use

MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

- 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,

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Image /page/15/Picture/1 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a red diamond shape with a white outline. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red underneath. Below the logo is the text "MicroPort Orthopedics Inc." in black.

- 4. revision procedures where other treatments or devices have failed
The MicroPort total hip systems devices are single use only devices.

The indications for use for the predicate systems are included in Table 2 below:

| 510(k) Number | Indication for Use | | | | |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| K864626 | This cancellous bone screw is indicated for use where screw purchase with cancellous bone is required. | | | | |
| K883618 | The Perfecta II Hip System is intended for cemented application only. The prosthesis system will be used in indications which are the same as indications for other cemented total hip designs such as the Zimmer Harris/Galante, the Biomet Bimetric, the Harris Precoat and the Howmedica Precision Hip System. Some indications include replacement of the femoral head and acetabular portions of the hip joint due to degenerative bone disease, trauma or complications from failed prostheses. | | | | |
| K893685 | The McCutchen Femoral Hip Prothesis is indicated for relief of pain and restoration of hip function in skeletally mature patients with: bicompartmental joint disease secondary to osteoarthritis, rheumatoid arthritis or traumatic arthritis, avascular necrosis of the femoral head, painful hip dyplasia, acute fracture of the femoral neck, protrusio acetabuli, ankylosis, revision procedures for which an adequate fit may be achieved by the operating surgeon at the time of surgery. This hip stem prosthesis can be used with all short, medium, and long 28 and 32mm Ceramic Femoral Heads. | | | | |
| K931333 | The intended use for the Orthomet Acetabular Cup System is identical to that of the acetabular cups of the Orthomet PERFECTA Total Hip System. The Orthomet Acetabular Cup is intended for cemented application only. Indications for the Orthomet Acetabular Cup will remain the same as indications for the original acetabular components of the PERFECTA Total Hip system and other acetabular cup systems currently available in commercial distribution, such as the Depuy Solution Acetabular Cup, Intermedics APR Acetabular Cup, Joint Medical Products S-ROM Acetabular Cup, Smith & Nephew Richards opti-Fix Acetabular Cup, and smith & Nephew Richards Reflection Acetabular Cup. Some indications include replacement of the femoral head and acetabular portions of the hip joint due to degenerative bone disease, trauma, or complications from failed prostheses. | | | | |
| K932222 | This femoral head can only be used with stems labeled for use with this product, and the stem labeling should be consulted to determine its compatibility with this product. The SLT Femoral Head may be used with appropriately sized polyethylene-lined acetabular cups or binolar endoprostheses. | | | | |
| 510(k) Number | Indication for Use | | | | |
| K944752 | The Orthomet Resurfacing Femoral Component (from this point forward referred to as<br>the Resurfacing Femoral Component) is intended for single use in a cemented<br>application only. The Resurfacing Femoral Component will be used in indications<br>which are the same as indications for other commercially available femoral resurfacing<br>components such as the Endotec Integrated Resurfacing Hip, DePuy Indiana<br>Conservative Hip, DePuy T.A.R.A. Hemi Articular Hip Replacement, and Zimmer<br>THARIES Surface Replacement System. Some indications include resurfacing of the<br>femoral head portion of the hip joint due to avascular necrosis, degenerative bone<br>disease, trauma, or complications from failed prostheses. | | | | |
| K953025 | The SLT 28mm XXL Femoral Head is indicated in total hip arthroplasty for reduction<br>or relief of pain and/or improved hip function in skeletally mature patients with the<br>following conditions:<br><br>1) Non-inflammatory degenerative joint disease such as osteoarthritis, avascular<br>necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;<br>2) Inflammatory degenerative joint disease such as rheumatoid arthritis;<br>3) Correction of functional deformity;<br>4) Revision procedures where other treatments or devices have failed; and<br>5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal<br>femur with head involvement that are unmanageable using other techniques. | | |…