REDAPT¿ Revision Femoral System

K151902 · Smith & Nephew, Inc. · LZO · Sep 3, 2015 · Orthopedic

Device Facts

• Record ID: K151902
• Device Name: REDAPT¿ Revision Femoral System
• Applicant: Smith & Nephew, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Sep 3, 2015
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. Smith & Nephew REDAPT™ Revision Hip System components are intended for single use only and are to be implanted without bone cement.

Device Story

REDAPT Sleeveless Monolithic Revision Stems are tapered, distally fixed femoral hip prostheses; intended for primary or revision hip surgery. Device implanted without bone cement; provides structural support for hip joint. Operated by orthopedic surgeons in clinical/surgical settings. Manufactured from forged titanium alloy (Ti-6Al-4V) with grit blast finish; features non-modular, fixed neck with 12/14 taper. Available in lengths 190mm, 240mm, 300mm and sizes 12-27. Device replaces failed hip components; restores joint function; aids in rehabilitation of damaged hips.

Clinical Evidence

No clinical data. Safety and effectiveness supported by bench testing, including fatigue strength and range of motion evaluations conducted in accordance with FDA guidance documents: 'Non-Clinical Information for Femoral Stem Prostheses' (2007) and 'Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked," Modular Implant Components' (1995).

Technological Characteristics

Material: Forged titanium alloy (Ti-6Al-4V). Design: Tapered, distally fixed femoral stem with grit blast finish and fixed 12/14 neck taper. Dimensions: 190mm, 240mm, 300mm lengths; sizes 12-27. Sterilization: Gamma irradiation. Non-modular, monolithic construction.

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, secondary 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 Modular Proximally Fluted Hip Stem (K113789)

Reference Devices

• REDAPT Modular Sleeved Revision Hip Stem (K121627)

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

September 3, 2015

Smith & Nephew, Incorporated Ms. Natalie Williams Senior Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K151902 Trade/Device Name: REDAPT™ Revision Femoral System 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, MEH Dated: July 8, 2015 Received: July 10, 2015

Dear Ms. Williams:

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

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Page 2 – Ms. Natalie Williams

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 yours,

# Lori A. Wiggins -S

for

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

Enclosure

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## Premarket Notification Indications for Use Statement

510(k) Number (if known):

Device Name: Smith & Nephew REDAPT™ Revision Femoral System

Indications for Use:

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.

Smith & Nephew REDAPT™ Revision Hip System components are intended for single use only and are to be implanted without bone cement.

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

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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| Submitted by: | Smith & Nephew, Inc.<br>Advanced Surgical Devices<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | July 8, 2015 |
| Contact Person and Address: | Natalie P. Williams<br>Sr. Regulatory Affairs Specialist<br>T: 901-399-5161<br>F: 901-566-7081 |
| Name of Device: | Smith & Nephew, Inc. REDAPT™ Revision Femoral System |
| Common Name: | Femoral Hip Prosthesis |
| Device Classification Name and<br>Reference: | 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-<br>constrained cemented or nonporous uncemented prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | MEH, LZO |

## Device Description

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

The REDAPT Sleeveless Monolithic Revision Stems are a modification of the primary predicate REDAPT Modular Proximally Fluted Hip Stem and reference predicate REDAPT Modular Sleeved Revision Hip Stem. The Sleeveless Monolithic Revision Stem is very similar to the predicate REDAPT hip stems in that it is a tapered, distally fixed femoral stem that is manufactured from forged titanium allov (Ti-6Al-4V) and has a grit blast finish. The subject device will be available in lengths of 190mm, 240mm, and 300mm and sizes 12-27, in 1mm increments. The REDAPT Sleeveless Monolithic Hip Stems will feature a non-modular, fixed neck with a 12/14 taper.

#### Intended Use

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.

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Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid 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.

Smith & Nephew REDAPT™ Revision Hip System components are intended for single use only and are to be implanted without bone 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

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.

## Substantial Equivalence Information

The intended use, indications for use, and technological characteristics of the Smith & Nephew REDAPT Sleeveless Monolithic Revision Stems are substantially equivalent to the femoral stems that currently exist as part of the REDAPT Revision Femoral System. A comparison of the subject devices to the predicate devices is provided in Table 5.1 below.

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| Design<br>Features | REDAPT Sleeveless<br>Monolithic Revision<br>Stems | Tanic v.<br>REDAPT Modular<br>Proximally Fluted<br>Hip Stem<br>(Primary Predicate) | REDAPT Modular<br>Sleeved Revision<br>Hip Stem<br>(Reference Predicate) |
|-------------------------------------------------|---------------------------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| 510(k) Number | Subject 510(k) | K113789 | K121627 |
| Manufacturer | Smith & Nephew, Inc. | Smith & Nephew, Inc. | Smith & Nephew, Inc. |
| Same<br>Indications for<br>Use/Intended<br>Use? | Yes | Yes | Yes |
| Size Offering | 12-27 | 12-27 | 11-27 |
| Stem Lengths<br>(mm) | 190mm, 240mm, and<br>300mm | 240mm; 300mm | 240mm; 300mm |
| Stem Material | Ti-6AL-4V | Ti-6AL-4V | Ti-6AL-4V |
| Fluted Tapered<br>Stem | Yes | Yes | Yes |
| Grit Blasted<br>Stem | Yes | Yes | Yes |
| Modular<br>Sleeves Used | No | No | Yes |
| Neck Taper | 12/14 | 12/14 | 12/14 |
| Modular Necks<br>Used | No | Yes | Yes |
| Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
| Equivalent<br>Manufacturing<br>Methods | Yes | Yes | Yes |

Table 5.1: Comparison of the Sleeveless Monolithic Hip Stems to Predicate Devices

# Conclusion

This Abbreviated 510(k) Premarket Notification is being submitted to request clearance for the REDAPT Sleeveless 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 above predicate constrained hip systems.