DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT

K012776 · Howmedica Osteonics Corp. · JWH · Nov 16, 2001 · Orthopedic

Device Facts

• Record ID: K012776
• Device Name: DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT
• Applicant: Howmedica Osteonics Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Nov 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Duracon® Constrained Posterior Stabilizer (PS) Tibial Inserts are intended to be used with legally marketed Duracon® tibial baseplates and wedges, Duracon® PS and TS femoral components, and patellar components as part of a total knee system in primary or revision cemented total knee arthroplasty. These inserts are intended to be used in cases where there is destruction of the joint surfaces with or without bone deformity, where the cruciate ligaments are inadequate, not present, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to absence of the patella. The collateral ligaments may or may not be present.

Device Story

Duracon® Constrained PS Tibial Insert is a component of a total knee system; used in primary or revision cemented total knee arthroplasty. Device features an intercondylar post that fits into the intercondylar cavity of Duracon® TS or PS femoral components; includes a metallic support bracket imbedded in the tibial insert with two metallic feet engaging the baseplate. Locking mechanism is secured by a hex head locking screw. Designed for cases with joint surface destruction, bone deformity, or inadequate/absent cruciate ligaments; provides stability when anterior-posterior stability is impaired, particularly following patellectomy. Used by orthopedic surgeons in clinical settings to restore joint function and stability.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by mechanical testing comparing the subject device to the predicate.

Technological Characteristics

Polymer/metal/polymer semi-constrained cemented knee prosthesis. Features include an intercondylar post, embedded metallic support bracket, and hex head locking screw for baseplate fixation. Designed for use with Duracon® tibial baseplates, wedges, and femoral components.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), rheumatoid arthritis, functional deformity, post-traumatic loss of joint anatomy (patello-femoral erosion/dysfunction/patellectomy), or irreparable knee fracture requiring primary or revision cemented total knee arthroplasty. Contraindicated in patients with overt infection, distant foci of infection, rapid disease progression, skeletal immaturity, or poor bone stock.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Duracon® TS tibial inserts (K973164)

Submission Summary (Full Text)

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KC012776 ા of 3

# NOV 1 6 2001

510(k) Summary Duracon® Constrained PS Tibial Inserts

### 510(k) Summary Duracon® Constrained PS Tibial Insert

#### Submission Information

| Name and Address of the Sponsor of the 510(k) Submission: | Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 |
|-----------------------------------------------------------|------------------------------------------------------------------|
| Contact Person: | Margaret F. Crowe Regulatory Affairs Consultant [phone] |
| Date of Summary Preparation: | August 10, 2001 |

**Date of Summary Preparation**

August 10, 2001

### Device Identification

| Proprietary Name: | Duracon® Constrained PS Tibial Insert |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Knee Prosthesis |
| Classification Name and Reference: | Knee Joint, Patellofemorotibial,<br>Polymer/Metal/Polymer, Semi-<br>Constrained, Cemented Prosthesis<br>21 CFR '888.3560 |

### Predicate Device Identification

The Duracon® Constrained PS Tibial Inserts are substantially equivalent to the Duracon® TS tibial inserts found substantially equivalent in premarket notification K973164.

## Device Description

The Duracon® Constrained PS tibial inserts share critical design features as the predicate Duracon® TS tibial inserts. Both designs incorporate an intercondylar post

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# KQ12776 2 of 3

#### 510(k) Summary Duracon® Constrained PS Tibial Inserts

which fits into the intercondylar cavity of the Duracon® TS or PS femoral component. Both designs have a metallic support bracket imbedded into the tibial insert at the time of manufacture. This bracket has two metallic feet which engage the posterior tabs of the baseplate during assembly. The insert-baseplate locking mechanism is augmented by a hex head locking screw in both designs.

## Intended Use

The intended use of the Duracon® Constrained PS tibial inserts is identical to that of the predicate Duracon® TS tibial bearing inserts. As with the predicate inserts, the new inserts are single use devices for use as part of a total knee system in primary or revision cemented total knee arthroplasty. These inserts are intended to be used in cases where there is destruction of the joint surfaces with or without bone deformity, where the cruciate ligaments are inadequate, not present, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to absence of the patella. The collateral ligaments may or may not be present.

## Indications

- Noninflammatory degenerative joint disease including osteoarthritis, traumatic t arthritis or avascular necrosis,
- . Rheumatoid arthritis,
- Correction of functional deformity, 을
- Revision procedures where other treatments or devices have failed, .
- Post-traumatic loss of joint anatomy, particularly when there is patello-femoral t erosion, dysfunction or prior patellectomy; and,
- . Irreparable fracture of the knee

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KO12776 3073

510(k) Summary Duracon® Constrained PS Tibial Inserts

# Contraindications

# Absolute contraindications include:

- 프 Overt infection,
- Distant foci of infections (which may cause hematogenous spread to the implant . site).
- Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram,
- . Skeletally immature patients
- Cases where there is poor bone stock which would make the procedure . unjustifiable.

# Conditions presenting an increased risk of failure include:

- Uncooperative patient or patient with neurological disorders who is incapable of 트 following instructions,
- . Osteoporosis,
- 트 Metabolic disorders which may impair bone formation,
- 트 Osteomalacia, and
- 트 Previous arthrodesis

# Performance Data

Mechanical testing has been performed to demonstrate the substantial equivalence of the subject inserts to the predicate inserts.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2001

Ms. Margaret Crowe Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K012776

Trade Name: Duracon® Constrained Posterior Stabilized (PS) Tibial Inserts Regulation Number: 888.3560 Regulation Name: Prothesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Regulatory Class: II Product Code: JWH Dated: August 17, 2001 Received: August 20, 2001

Dear Ms.Crowe:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Margaret Crowe

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

fo Mark n Millburn

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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# 1012776

### 510(k) Number (if known): K

NOV 1 6 2001

Duracon® Constrained PS Tibial Insert Device Name:

The Duracon® Constrained Posterior Stabilizer (PS) Tibial Inserts are intended to be used with legally marketed Duracon® tibial baseplates and wedges, Duracon® PS and TS femoral components, and patellar components as part of a total knee system in primary or revision cemented total knee arthroplasty. These inserts are intended to be used in cases where there is destruction of the joint surfaces with or without bone deformity, where the cruciate ligaments are inadequate, not present, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to absence of the patella. The collateral ligaments may or may not be present. More specific indications/contraindications are listed below:

#### Indications

- Noninflammatory degenerative joint disease including osteoarthritis, traumatic 트 arthritis or avascular necrosis,
- Rheumatoid arthritis, ■
- Correction of functional deformity, .
- Revision procedures where other treatments or devices have failed, 사
- Post-traumatic loss of joint anatomy, particularly when there is patello-femoral 트 erosion, dysfunction or prior patellectomy; and,
- в Irreparable fracture of the knee

to Mark N. Mulkerson

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K012776
510(k) Number