REFLECTION CONSTRAINED LINER

K021803 · Smith & Nephew, Inc. · KWZ · Dec 19, 2002 · Orthopedic

Device Facts

• Record ID: K021803
• Device Name: REFLECTION CONSTRAINED LINER
• Applicant: Smith & Nephew, Inc.
• Product Code: KWZ · Orthopedic
• Decision Date: Dec 19, 2002
• Decision: SESE
• Submission Type: Abbreviated
• 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-perative instability and for whom all other options to constrained acetabular components have been considered.

Device Story

Reflection Constrained Liner is a hip joint prosthesis component designed to reduce dislocation risk. It functions as a constrained acetabular liner, used in conjunction with existing Reflection Acetabular Shells and 28 mm metal femoral heads. It is implanted by orthopedic surgeons in clinical settings during primary or revision hip replacement procedures. The device provides mechanical constraint to the femoral head within the acetabular shell, addressing instability caused by patient-specific factors like soft tissue laxity or neuromuscular disease. It is compatible with various femoral stems, provided a 28 mm metal head is used; ceramic or skirted heads are contraindicated. The device is intended for patients where standard acetabular components are insufficient to maintain joint stability.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by materials data and bench testing performed in accordance with FDA guidance documents for hip joint prostheses.

Technological Characteristics

Constrained acetabular liner for use with Reflection Acetabular Shells. Materials include metal/polymer construction. Compatible only with 28 mm metal femoral heads. Designed for cemented or uncemented fixation. Testing conducted per Class II Special Controls Guidance for Hip Joint Metal/Polymer Constrained and Uncemented Prosthesis (April 2002), UHMWPE guidance (1997), and Acetabular Cup Prosthesis testing guidance (1995).

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 intraoperative 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 Acetabular Component
• Johnson & Johnson S-Rom Poly-Dial Constrained Liner
• Osteonics Constrained Acetabular Insect
• Zimmer Triology Acetabular System

Submission Summary (Full Text)

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## KOZ1803 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: | DEC 1 9 2002<br>May 31, 2002 |
| Contact Person: | Janet Johnson Akil- Director, Regulatory Affairs |
| 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 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-perative instability and for whom all other options to constrained acetabular components have been considered.

#### B. DEVICE DESCRIPTION

The Reflection 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 (28 mm only) and Reflection 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 28 mm metal femoral heads is used with the femoral component. Ceramic heads or skirted femoral heads of any material should not be used with the Reflection Constrained Liner.

#### C. SUBSTANTIAL EQUIVALENCE INFORMATION

The Reflection Constrained Liner is similar to the following: A) Reflection Acetabular Component B) Johnson & Johnson S-Rom Poly-Dial Constrained Liner C) Osteonics Constrained Acetabular Insect and D) 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 equivalence information, materials data, and testing results provided within this Abbreviated Notification. Such information 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, 2002 and Guidance Documents For Utra-high Molecular Weight Polyethylene (UHMWPE) Used In Bearing Surfaces For Orthopedic Devices, dated September 7, 1997 and Guidance Document for Testing Acetabular Cup Prosthesis (dated May 1, 1995)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 9 2002

Ms. Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116

Re: K021803

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: Class II Product Code: KWZ Dated: September 18, 2002 Received: September 20, 2002

Dear Ms. Akil:

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 -- Ms. Janet Johnson Akil

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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

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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#### 510(k) Number K021803

Device 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 intraoperative 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.

### Concurrence of CDRH, Office of Device Evaluation

Prescription Use

OR Over-The Counter Use __________ (Per 21 CFR 801.109)

Miriam C. Provost

ivision of General, Restorative and Neurological Devices

19(k) Number K0 21803