SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS

K052748 · Howmedica Osteonics Corp. · JDI · Dec 2, 2005 · Orthopedic

Device Facts

• Record ID: K052748
• Device Name: SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS
• Applicant: Howmedica Osteonics Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Dec 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Orthopaedics System 12® X3™ Acetabular insert and Series II™ X3™ Acetabular insert components are single use sterile components intended for the replacement of the bearing and/or articulating surfaces of the acetabulum to relieve pain, and the restriction of motion.

Device Story

System 12® and Series II™ X3™ Acetabular Inserts are single-use, sterile orthopedic components for total hip arthroplasty. These inserts serve as the bearing surface within an acetabular shell, articulating with a femoral head. Used in clinical settings by orthopedic surgeons during cemented or cementless hip replacement procedures. The device addresses pain, instability, and restricted motion caused by degenerative joint disease, trauma, or previous surgical failure. The modification introduces a sequentially crosslinked and annealed polyethylene material, sterilized via STERRAD gas plasma. By providing a durable, low-wear bearing surface, the inserts aim to restore hip function and alleviate patient discomfort.

Clinical Evidence

No clinical data. Bench testing only: material properties characterization, wear testing, disassembly force evaluation, and finite element modeling of contact stresses.

Technological Characteristics

Acetabular inserts for total hip arthroplasty. Material: Sequentially crosslinked and annealed polyethylene. Sterilization: STERRAD gas plasma. Form factor: Designed for integration with associated acetabular shells, femoral bearings, and femoral hip stems.

Indications for Use

Indicated for patients requiring cemented or cementless total hip replacement/arthroplasty due to noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, post-traumatic arthritis, functional deformity, revision of failed prior procedures, nonunion, or femoral neck/trochanteric fractures. Also indicated for clinical management problems where alternative reconstructive techniques are less likely to achieve satisfactory results or where bone stock is poor/inadequate.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• System 12® and Series II™ Hip System Acetabular Inserts

Submission Summary (Full Text)

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System 12® and Series II™ X3™ Acetabular Inserts

510(k) Premarket Notification

## Summary of Safety and Effectiveness

| | DEC 2 2005 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karen Ariemma<br>Senior Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>[phone]<br>[phone] (FAX) |
| Date: | November 29, 2005 |
| Device: | System 12® X3™ Acetabular Inserts<br>Series II™ X3™ Acetabular Inserts |
| Classification: | Prosthesis Hip, Semi-Constrained, Porous Coated, Uncemented<br>prosthesis: 21 CFR §888.3358<br><br>Hip Joint Metal/Ceramic/Polymer Semi-constrained cemented or<br>nonporous uncemented prosthesis: 21 CFR §888.3353<br><br>Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis,<br>21 CFR §888.3350 |
| Device Product Codes: | 87 JDI, 87 LPH, 87 LZO, and 87 MEH |
| Predicate Devices: | System 12® and Series II™ Hip System Acetabular Inserts |

**Intended Use:** The Stryker Orthopaedics System 12® X3™ Acetabular insert and Series II™ X3™ Acetabular insert components are single use sterile components intended for the replacement of

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System 12® and Series II™ X3™ Acetabular Inserts

510(k) Premarket Notification

the bearing and/or articulating surfaces of the acetabulum to relieve pain, and the restriction of motion.

**Indications for Use:** The System 12® X3™ Acetabular Inserts are single use sterile components, intended for use in conjunction with associated acetabular shells, femoral bearings, and femoral hip stems as part of a cemented or cementless total hip replacement procedure. Indications for use are as follows: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed, and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Series II™ X3™ Acetabular Inserts are single use sterile components, intended for use in conjunction with an associated Howmedica Osteonics metal acetabular shell, femoral bearing, and femoral hip stem as part of a cemented or cementless total hip arthroplasty. Indications for use are as follows: painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis; revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure; clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results; and where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Proposed Modification: Addition of new polyethylene components of a modified sequentially crosslinked and annealed material which has undergone a STERRAD gas plasma sterilization.

Device Description: The device includes the acetabular inserts of a total hip system. These components are used for the replacement of the bearing surface of the acetabulum to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.

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System 12® and Series II™ X3™ Acetabular Inserts

510(k) Premarket Notification

Summary of Data: A risk analysis and research and development testing have been performed to demonstrate equivalence of the subject products to the predicate devices. Testing and analysis include material properties characterization, wear testing, disassembly force evaluation, and finite element modeling of contact stresses.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 caduceus symbol, featuring a staff with a snake winding around it.

DEC 2 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Karen Ariemma Senior Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430

Re: K052748

Trade/Device Name: System 12® X3"" Acetabular Inserts, Series II" X3"" Acetabular Inserts Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: JDI, LPH, LZO, MEH Dated: September 29, 2005 Received: September 30, 2005

Dear Ms. Ariemma:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 approvisions 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 devices is classified (see above) into either class II (Special Controls) or class III (PMA), they 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 devices comply 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 CIFR 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 - Karen Ariemma

This letter will allow you to begin marketing your devices as described in your Section 510(k) This letter will anow you to begal mainer.ing your antial equivalence of your devices to a legally premarket notification: "The PDT Intering of cation for your device and thus, permits your devices to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrite for your at [phone]. Also, please note the regulation entitled, Colliact the Office of Comphalled at (21 ) notification" (21CFR Part 807.97). You may obtain Misolanding of reference to prementonibilities under the Act from the Division of Small other general informational 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,

Z

Sor Mark N. Melkerson Acting 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 (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: System 12® X3™ Acetabular Inserts

**Indications for Use:** The System 12® X3™ Acetabular Inserts are single use sterile components, intended for use in conjunction with associated acetabular shells, femoral bearings, and femoral hip stems as part of a cemented or cementless total hip replacement procedure. Indications for use are as follows:

- noninflammatory degenerative joint disease including osteoatrthritis and avascular . necrosis,
- rheumatoid arthritis, .
- correction of functional deformity, .
- revision procedures where other treatments or devices have failed, and .
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.

Over-the-Counter Use X ___ OR Prescription Use (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

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

Page 1 of 2

**510(k) Number** K052748

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Series II™ X3™ Acetabular Inserts

Indications for Use:

The Series II" X3™ Acetabular Inserts are single use sterile components, intended for use in conjunction with an associated Howmedica Osteonics metal acetabular shell, femoral bearing, and femoral hip stem as part of a cemented or cementless total hip arthroplasty. Indications for use are as follows:

- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other . procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques . are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum.

Prescription Use X ___________________________________________________________________________________________________________________________________________________________

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)

## (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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| (Division Sign-Off) | |

| Division of General, Restorative, and Neurological Devices | |
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| 510(k) Number | K052748 |
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