EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS

K071676 · Exactech, Inc. · KWZ · Jul 19, 2007 · Orthopedic

Device Facts

• Record ID: K071676
• Device Name: EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS
• Applicant: Exactech, Inc.
• Product Code: KWZ · Orthopedic
• Decision Date: Jul 19, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Exactech Novation Crown Cup TM Constrained Liners and Rings are components of the Exactech Novation® non-cemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and are compatible with Exactech press-fit or cemented femoral stem components.

Device Story

Constrained acetabular liners and rings for hip arthroplasty; components of Novation non-cemented acetabular cup system. Liners feature sphere/taper inner geometry, modified petal height, and increased constraining diameter to improve range-of-motion and lever-out moment. Rings utilize locking mechanism to snap into cup. Used by orthopedic surgeons in clinical settings for patients at high risk of hip dislocation. Provides mechanical constraint to prevent joint dislocation. Subject device modifies predicate AcuMatch A-Series liners; ring material updated to Ti-6Al-4V (ASTM F1472).

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Constrained acetabular liners and rings. Rings constructed of Ti-6Al-4V per ASTM F1472. Liners feature sphere and taper inner diameter geometry. Designed for press-fit fixation in acetabular cups. Compatible with press-fit or cemented femoral stems. Mechanical locking mechanism for ring-to-cup interface.

Indications for Use

Indicated for primary or revision hip arthroplasty patients at high risk of dislocation (history of dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability) where other constrained options are unsuitable.

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

• AcuMatch A-Series & MCS Constrained Liners (K040601)

Submission Summary (Full Text)

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# K071676

## Exactech® Novation Crown Cup TM Constrained Liners and Rings Special 510(k) - 510(k) Summary

#### Trade or proprietary or model name(s): Novation Crown Cup TM Constrained Liners and Rings

JUL 1 9 2007

Common Name Constrained Liners and Rings

## Classification name

Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR Section 888.3310)

### Information on devices to which substantial equivalence is claimed:

| 510(k)<br>Number | Trade or Proprietary or Model Name | Manufacturer |
|------------------|--------------------------------------------|----------------|
| #K040601 | AcuMatch A-Series & MCS Constrained Liners | Exactech. Inc. |

### Indications for Use:

Novation Crown Cup ™ Constrained Liners and Rings are components of the Exactech Novation® non-cemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and are compatible with Exactech press-fit or cemented femoral stem components.

### Device Description:

The proposed Novation® Constrained Acetabular Liners are modifications of the previously cleared AcuMatch A-Series predicates. The design features of the subject devices are summarized below:

### NOVATION CONSTRAINED LINERS

- Sphere and taper inner diameter geometry for compatibility with the Novation . Crown Cup
- Increased range-of-motion and lever-out moment by decreasing the height of the . constraining petals, increasing the constraining diameter and increasing the lead in chamfer
- Addition of a 36mm ID option. .

### NOVATION CONSTRAINED RINGS

- The constraining ring will be made of Ti-6Al-4V per ASTM F1472 instead of Ti-� 6Al-4V per ASTM F136.

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# KO71676 Exactech® Novation Crown Cup ™ Constrained Liners and Rings Special 510(k) - 510(k) Summary

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- Ring snaps into a locking feature on the Novation Crown Cup instead of press-. fit.
- Inner and outer diameter of the constraining ring modified for compatibility with . the proposed constrained liner and Novation Crown Cup.

#### Substantial Equivalency Conclusion:

Engineering evaluations were conducted to verify that the performance of the proposed acetabular components would be adequate for anticipated in vivo use. Based on successful results discussed in this submission, we conclude that the proposed devices are substantially equivalent to the previously cleared predicates.

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Image /page/2/Picture/12 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of what appears to be an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Exactech, Inc. % Mr. Graham Cuthbert Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653

JUL 1 9 2007

Re: K071676

Trade/Device Name: Novation Crown Cup™ Constrained Liners and Rings 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: June 15, 2007 Received: June 19, 2007

Dear Mr. Cuthbert:

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 - Graham Cuthbert

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Barbara Buehrig

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Exactech® Novation Crown Cup ™ Constrained Liners and Rings Special 510(k) - Indications for Use

| 510(k) Number: | K071676 |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Exactech Novation Crown Cup TM Constrained Liners and Rings |
| Intended Use: | Exactech Novation Crown Cup TM Constrained Liners and Rings are components of the Exactech Novation® non-cemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and are compatible with Exactech press-fit or cemented femoral stem components. |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X and/or Over-The-Counter Use<br>(21 CFR 807 Subpart C) |

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Charlane Bovehir

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

**510(k) Number** K071671

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