REDAPT Sleeved Monolithic Revision Stems

K162303 · Smith & Nephew, Inc. · MEH · May 1, 2017 · Orthopedic

Device Facts

• Record ID: K162303
• Device Name: REDAPT Sleeved Monolithic Revision Stems
• Applicant: Smith & Nephew, Inc.
• Product Code: MEH · Orthopedic
• Decision Date: May 1, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The REDAPT Sleeved Monolithic Revision Stems are indicated for: Hip components are 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; 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 REDAPT Revision Hip System (formerly MDF) is intended to be used without cement.

Device Story

REDAPT Sleeved Monolithic Revision Stems are femoral hip prostheses designed for uncemented fixation in primary or revision hip arthroplasty. Device functions as structural replacement for damaged proximal femur; restores joint function. Used in surgical settings by orthopedic surgeons. Input is patient anatomy; device provides mechanical support for hip joint. Benefits include rehabilitation of hip function following failure of previous treatments or severe joint disease. Device is monolithic stem design; integrates into existing REDAPT Revision Femoral System. Clinical decision-making relies on surgeon assessment of patient bone quality and joint pathology.

Clinical Evidence

No clinical data. Safety and effectiveness supported by bench testing, including fatigue strength, range of motion, and taper corrosion/fretting analysis compared to predicate devices. Bacterial endotoxin testing performed per ANSI/AAMI ST-72.

Technological Characteristics

Femoral hip prosthesis; uncemented; monolithic stem design. Materials and design consistent with existing REDAPT Revision Femoral System. Testing performed per FDA guidance for femoral stem prostheses and modular implant components. Sterilization via standard methods (implied).

Indications for Use

Indicated for individuals undergoing primary and revision hip surgery due to trauma, noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, diastrophic variant), inflammatory degenerative joint disease (rheumatoid arthritis, congenital dysplasia), nonunion, femoral neck/trochanteric fractures, endoprosthesis, femoral osteotomy, Girdlestone resection, fracture-dislocation, or deformity correction.

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

• REDAPT Sleeveless Monolithic Stem (K151902)
• REDAPT Modular Sleeved Revision Hip Stem (K121627)
• MDF Revision Hip System (K081124)
• S-ROM Hip Stem (K954935)
• S-ROM Hip Stem (K961939)
• Emperion Hip System (K042127)
• Emperion Hip System (K052426)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 1, 2017

Smith & Nephew, Inc. Ms. Kim Phan Regulatory Affairs Specialist Advanced Surgical Devices Division 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K162303 Trade/Device Name: REDAPT Sleeved Monolithic Revision Stems 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: MEH, LZO Dated: March 31, 2017 Received: April 3, 2017

Dear Ms. Kim Phan:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

510(k) Number (if known) K162303

Device Name

REDAPT Sleeved Monolithic Revision Stems

#### Indications for Use (Describe)

The REDAPT Sleeved Monolithic Revision Stems are indicated for:

· Hip components are 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 (NID) ) 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, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; 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 REDAPT™ Revision Hip System (formerly MDF) is intended to be used without cement.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 10px;"> X </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 10px;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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### 510(k) Summary Smith & Nephew, Inc. REDAPT Sleeved Monolithic Revision Stems

| Submitted by: | Smith & Nephew, Inc.<br>Advanced Surgical Devices Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | September 30th, 2016 |
| Contact Person | Kim Phan, Regulatory Affairs Specialist<br>T: [phone]<br>F: [phone] |
| Name of Device: | REDAPT Sleeved Monolithic Revision<br>Stems |
| Common Name: | Femoral Hip Prosthesis |
| Device Classification Name and Reference: | 21 CFR 888.3353 – Hip joint<br>metal/ceramic/polymer semi-constrained<br>cemented or nonporous uncemented<br>prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | MEH, LZO |

#### Predicate:

| Manufacturer | Description | Submission<br>Number | Clearance Date |
|--------------------------|---------------------------------------------|----------------------|----------------|
| Smith & Nephew, Inc. | REDAPT Sleeveless Monolithic Stem | K151902 | 09/03/2015 |
| Smith & Nephew, Inc. | REDAPT Modular Sleeved Revision Hip<br>Stem | K121627 | 10/15/2012 |
| Smith & Nephew, Inc. | MDF Revision Hip System | K081124 | 7/31/2008 |
| Depuy Orthopaedics, Inc. | S-ROM Hip Stem | K954935 | 01/22/1996 |
| Depuy Orthopaedics, Inc. | S-ROM Hip Stem | K961939 | 08/13/1996 |
| Smith & Nephew, Inc. | Emperion Hip System | K042127 | 11/19/2004 |
| Smith & Nephew, Inc. | Emperion Hip System | K052426 | 12/07/2005 |

#### Device Description

Subject of this Abbreviated premarket notification is the addition of a new stem design to the Smith & Nephew REDAPT Revision Femoral System which are Femoral Components part of Smith & Nephew's Total Hip System. The REDAPT Revision Femoral System currently consists of the Modular Proximally Fluted Hip Stems cleared by K113789, the Modular Sleeved Revision Hip Stems cleared by K121627, and the Monolithic Sleeveless Hip Stems cleared on K151902. The proposed devices are the REDAPT Sleeved Monolithic Revision Stems, new hip stems that will be marketed as part of the REDAPT Revision Femoral System.

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#### Intended Use

The REDAPT Sleeved Monolithic Revision Stems are indicated for:

- Hip components are 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; 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 REDAPT® Revision Hip System (formerly MDF) is intended to be used without cement.

#### Technological Characteristics

Performance testing has been conducted for the subject devices in accordance with the following guidance documents:

- Non-Clinical Information for Femoral Stem Prostheses, dated September 2007 ●
- Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked," Modular . Implant Components, dated May 1995

Additional testing was completed and is briefly described below:

- Taper analyses were completed on the subject and predicate devices to examine the ● taper after corrosion testing was completed. This quantified the depth of material loss at the taper which was able to be compared to the predicate.
- . Additional fretting fatigue testing was completed to evaluate the fretting induced corrosion of the subject and predicate device.
- o Disassembly and taper analysis were also completed after this test to compare to the predicate.

Fatigue strength and range of motion testing have also been evaluated. A review of testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.

Bacterial endotoxin testing was completed on representative samples and met the acceptable endotoxin limits as stated in the FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST-72.

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#### Substantial Equivalence Information

The intended use, indications for use and technological characteristics of the Smith & Nephew REDAPT Sleeved Monolithic Stems are substantially equivalent to the femoral stems that currently exist as part of the REDAPT Revision Femoral System.

#### Conclusion

This Abbreviated 510(k) Premarket Notification is being submitted to request clearance for the REDAPT Sleeved Monolithic Revision Stems. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the above predicate hip systems.