REFLECTION CONSTRAINED LINER

K033442 · Smith & Nephew, Inc. · KWZ · Nov 26, 2003 · Orthopedic

Device Facts

• Record ID: K033442
• Device Name: REFLECTION CONSTRAINED LINER
• Applicant: Smith & Nephew, Inc.
• Product Code: KWZ · Orthopedic
• Decision Date: Nov 26, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reflection Constrained Liner is a cemented or uncemented prosthesis intended to replace a hip joint. The Reflection Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all other options to constrained acetabular components have been considered. The components subject of this notification are to be used with the Reflection Acetabular System, which is indicated for use with or without cement, and includes single use devices.

Device Story

The Reflection Constrained Liner is an orthopedic acetabular component used to replace a hip joint. It functions as a constrained liner within the Reflection Acetabular Shell to prevent dislocation. It is compatible with 22, 26, 28, and 32 mm metal femoral heads; ceramic or skirted heads are contraindicated. The device is implanted by orthopedic surgeons during primary or revision hip surgery. It provides mechanical stability to the hip joint in patients with high risk of dislocation. The device is used in clinical settings (hospitals/surgical centers).

Clinical Evidence

Bench testing only. No clinical data provided. Testing conducted per FDA guidance for hip joint metal/polymer constrained prostheses and UHMWPE bearing surfaces.

Technological Characteristics

Metal/polymer constrained acetabular prosthesis. Components include a liner for use with Reflection Acetabular Shells. Compatible with 22, 26, 28, and 32 mm metal femoral heads. Materials and design features are consistent with predicate devices. Testing performed per Class II Special Controls Guidance Document for Hip Joint Metal/Polymer Constrained and Uncemented Prosthesis.

Indications for Use

Indicated for primary or revision hip arthroplasty patients at high risk of dislocation due to prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability, where other constrained options have been considered.

Regulatory Classification

Identification

A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”

Predicate Devices

• Reflection Constrained Liner (28 mm)
• Reflection Acetabular Component
• Johnson & Johnson S-Rom Poly-Dial Constrained Liner
• Osteonics Constrained Acetabular Insert
• Zimmer Triology Acetabular System

Submission Summary (Full Text)

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NOV 2 6 2003

K 033 442 pge141

# 510(K) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS Reflection Constrained Liner

| Submitted By | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 Brooks Road<br>Memphis, TN 38116 |
|-------------------------------------|-------------------------------------------------------------------------------------------------|
| Date: | October 28, 2003 |
| Contact Person: | Kanu Vadodaria - Sr. Regulatory/Clinical Affairs Specialist |
| Proprietary Name: | Reflection Constrained Liner |
| Common Name: | Constrained Liner |
| Classification Name and Reference: | 888.33 10 - Hip Joint Metal/Polymer Constrained<br>Cemented or Uncemented Prosthesis - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/KWZ |

#### A. INTENDED USE

The Retlection Constrained Liner construct is a cemented prosthesis intended to replace a hip joint. The Reflection Constrained Liner is intended for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all othe · options to constrained acetabular components have been considered.

#### B. DEVICE DESCRIPTION

The Re lection Constrained Liner is used with existing appropriately sized Reflection Acetabular Shells. The Reflection Constrained Liner can be used with previously implanted femoral components, femoral heads (22, 26, 28, and 32 mm) and Relection Acetabular Shells such as in a revision case, or it may be used in primary cases and implanted along with the shell, head and stem. Any appropriately sized Reflection Shell may be utilized. Any stem may be used, provided a 22, 26, 28, or 32 mm metal femoral head is used with the femoral component. Ceramic heads or skirted femoral heads of any naterial should not be used with the Reflection Constrained Liner.

### C. SUBSTANTIAL EQUIVALENCE INFORMATION

The R . flection Constrained Liner is similar to the following: A) Reflection Constrained Liner (28 mm) B) Reflection Acetal ular Component C) Johnson & Johnson S-Rom Poly-Dial Constrained Liner D) Osteonics Constrained Acetalvular Insert and E) Zimmer Triology Acetabular System.

### D. SUMMARY OF TECHNOLOGICAL COMPARISON

The intended use, material, type of interface and design features of the Reflection Constrained Liner are similar to their predicate counterparts. The safety and effectiveness of this device are adequately supported by the substantial equiv lence information, materials data, and testing results provided within this Special Premarket Notification. Such infornation was generated per data requirements outlined in the Class II Special Controls Guidance Document: Hip Joint Metal Polymer Constrained and Uncemented Prosthesis; Guidance for Industry and FDA dated April 30, 21/02 and Guidance Document for Data Requirements For Ura-high Polyethylene (UHMWPE) Used In Bearing Surfaces For Orthopedic Devices, dated September 7, 1997 and Guidance Document for Testing Acetc bular Cup Prosthesis (dated May 1, 1995).

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NOV 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kanu Vadodaria Senior Regulatory/Clinical Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis. Tennessee 38116

Re: K033442

Trade/Device Name: Reflection Constrained Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: October 28, 2003 Received: October 29, 2003

Dear Mr. Vadodaria:

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 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.

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Page 2 - Mr. Kanu Vadodaria

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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Mark A. Milkeison

Celia M. Witten, Ph.D., M.D. 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 Statement Reflection Constrained Liner

5 | 0(k) Number (if known): K0}344L

I evice Name: Reflection Constrained Liner

Indications for Use:

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

The components subject of this notification are to be used with the Reflection Acetabular System, which is indicated for use with or without cement, and includes single use devices.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use No
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K033442