PATIENT MATCHED HIP STEM

K053246 · Smith & Nephew, Inc. · LZO · Jul 12, 2006 · Orthopedic

Device Facts

• Record ID: K053246
• Device Name: PATIENT MATCHED HIP STEM
• Applicant: Smith & Nephew, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Jul 12, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew Patient Matched Hip Stem is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The REFLECTION Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The Endoprostheses System is indicated for non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis; rheumatoid arthritis; arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis; revision procedures where other treatments have failed; and treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement. The Patient Matched Hip Stem is for uncemented, single use only.

Device Story

Patient Matched Hip Stem (PMHS) is an anatomic-style femoral hip implant; geometry derived from patient-specific x-rays to match individual anatomy. Used in primary or revision hip arthroplasty; intended for uncemented, single-use application. Surgeon shapes implant based on patient imaging; device replaces damaged hip joint to restore function. Benefits include improved anatomical fit for patients with complex hip pathology or failed prior treatments. Operated by orthopedic surgeons in clinical/hospital settings.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Anatomic-style femoral hip stem; patient-matched geometry derived from x-ray imaging. Uncemented, single-use device. Materials and design consistent with established hip arthroplasty standards for metal/polymer/ceramic semi-constrained or constrained prostheses.

Indications for Use

Indicated for patients undergoing primary or revision hip surgery due to trauma, noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis, traumatic arthritis, etc.), inflammatory degenerative joint disease (rheumatoid arthritis, congenital dysplasia), or proximal femoral fractures/non-union. Includes patients with remote osteomyelitis (with warnings). Constrained liner indicated for high-risk dislocation patients (prior dislocation, bone loss, soft tissue laxity, neuromuscular disease).

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

• Smith & Nephew Synergy Global Taper Hip System (K963509)
• Smith & Nephew ANTHOLOGY Hip Stem (K052792)
• Biomet Patient Matched Implants (K923452)

Reference Devices

• REFLECTION Constrained Liner Acetabular System
• Endoprostheses System

Submission Summary (Full Text)

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Koszuk Page 1/2

JUL 1 2 2006

# 510(k) Summary Smith & Nephew Patient Matched Hip Stem (PMHS)

| Submitter's Name: | Smith & Nephew, Inc., Orthopaedic Division |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 1450 Brooks Road, Memphis, TN 38116 |
| Submitter's Telephone Number: | 901-399-5042 |
| Contact Person: | Laurie Jordan |
| Date Summary Prepared: | November 16, 2005 |
| Trade or Proprietary Device Name: | Patient Matched Hip Stem |
| Common or Usual Name: | Hip Stem |
| Classification Name: | 21 CFR 888.3353,<br>Hip Joint metal/ceramic/polymer semi-constrained<br>cemented or nonporous uncemented prosthesis<br>21 CFR 888.3310,<br>Hip Joint metal/polymer constrained cemented or<br>uncemented prosthesis<br>21 CFR 888.3360,<br>Hip Joint femoral (hemi-hip) metallic cemented or<br>uncemented prosthesis<br>21 CFR 888.3390<br>Hip joint femoral (hemi-hip) metal/polymer cemented<br>or uncemented prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87/LZO, MEH, KWL, KWZ, KWY |

## Device Description

The Patient Matched Hip Stem, hereafter referred to as the PMHS, is an anatomic style stem that has been developed to match the hip anatomy of a particular patient. The hip stem geometry is derived by allowing the surgeon to shape the implant based on an x-ray of the patient's anatomy.

#### Intended Use

The Smith & Nephew Patient Matched Hip Stem is individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips dammed as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old. remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femor beck fracture and trochanteric fractures of the proximal femur with head involvement that are unmonageable using other techniques; endoprosthesis, femoral ostedtomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

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The REFLECTION Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.

The Endoprostheses System is indicated for non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis, rheumatoid arthritis; arthritis secondary to a variety of diseases and anomalies and correction of functional deformity, ch as congenital hip dysplasia or ankylosing spondylitis; revision procedures where other treatments have failed; and treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.

The Patient Matched Hip Stem is for uncemented, single use only.

#### Substantial Equivalence

The intended use, design, and materials of the Smith & Nephew Patient Matched Hip Stem are substantially equivalent to the Smith & Nephew Synergy Global Taper Hip System (K963509), the Smith & Nephew ANTHOLOGY Hip Stem (K052792), and the Biomet Patient Matched Implants (K923452).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of a human figure, with three curved lines forming the body and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2006

Mr. John Reabe Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis. Tennessee 38116

Re: K053246

> Trade/Device Name: Patient Matched Hip Stem 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 Codes: LZO, KWL, KWY, KWY, KWZ, MEH Dated: May 9, 2006 Received: May 11, 2006

Dear Mr. Reabe:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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#### Page 2 - Mr. John Reabe

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Deubere Melker
Mark N. Melkerson, M.S.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE

### 510(k) Number (if known): K053246

Device Name: Smith & Nephew Patient Matched Hip Stem (PMHS)

### Indications for Use:

The Smith & Nephew Patient Matched Hip Stem is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracturedislocation of the hip; and correction of deformity.

The REFLECTION Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.

The Endoprostheses System is indicated for non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis: rheumatoid arthritis; arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis; revision procedures where other treatments have failed; and treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.

The Patient Matched Hip Stem is for uncemented sing

Division of General, Restorative, and Neurological Devices

510(k) Number V053214

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X Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

.

Over-The-Counter Use (21 CFR 807 Subpart Cl

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Seibare Buchum

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K053346