ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS

K992235 · Corin USA · LZO · Nov 23, 1999 · Orthopedic

Device Facts

• Record ID: K992235
• Device Name: ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS
• Applicant: Corin USA
• Product Code: LZO · Orthopedic
• Decision Date: Nov 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zirconia Ceramic Modular Heads are used in combination with femoral hip stems and ultra high molecular weight polyethylene (UHMWPE) acetabular cups or acetabular cup liners to reinstate function following the degenerative effects of osteo or rheumatoid arthritis, post-trauma disease effects, avascular necrosis and septic or aseptic total hip revision.

Device Story

Zirconia ceramic modular heads (Y-TZP) for total hip replacement; designed to articulate with UHMWPE acetabular cups/liners. Device features female taper (trunnion) for attachment to Corin Medical femoral stems. Available in various neck lengths and 28mm/32mm diameters. Ceramic surface provides low friction, decreased torque, and resistance to third-body wear from cement particles; eliminates metallic corrosion particulates associated with cobalt-chromium heads. Used by orthopedic surgeons in clinical settings to reduce polyethylene wear and associated osteolysis.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and material properties.

Technological Characteristics

Material: Yttria-stabilized tetragonal zirconia polycrystals (Y-TZP). Form factor: Modular femoral heads with female taper, 28mm/32mm diameters. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring total hip replacement to restore function due to osteoarthritis, rheumatoid arthritis, post-traumatic disease, avascular necrosis, or septic/aseptic revision.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Submission Summary (Full Text)

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WO 23 1000

## K 99 2235 510(k) SUMMARY

- Corin Medical Name of Company: The Corinium Centre Cirencester Gloucestershire GI.7 1 YJ England
Zyranox Zirconia Ceramic Modular Heads Name of Device:

Device Description:

Device Dooriphon. Polycrystals (Y-TZP), used in total hip replacement surgery.

These Zirconia Ceramic Modular Heads are available in standard Corin trunnion and Euroconc trunnion options. The devices are available in short, standard and long neck and 28mm and 32mm outside diameters.

The bore of the Modular Head is designed so as to ensure compatibility with the conc (trunnion) of the Femoral Stem, and hence locking of the components in situ.

The Corin Medical Zirconia ceramic modular heads incorporate a female trumion (taper). The modular head is applied to the male trunnion of a Corin Medical femoral stom.

The Zirconia ccramic modular heads are designed to articulate with ultra high molecular weight polyethylene (UHMWPE) acetabular cups or acctabular cup liners to roinstate function following the degenerative effects of osteo or theumatoid arthritis, post-trauma disease effects, avascular necrosis and septic total hip revision.

Zirconia ccramic modular heads offer an ultra smooth surface in order to decrease torque and reduce stresses normally associated with the articulation of cobalt chromium alloy femoral heads with ultra high molecular weight polycthylene (UHMWPF) acctabular components.

7.rconia ceramic modular heads are more resistant to third body wear from coment particles than cobalt chromium alloy modular heads. This, in conjunction with their low friction and decreased torque, significantly reduces polycthylene wear related total hip prosstheses problems such as ostcolysis.

The use of zirconia ceramic modular heads also eliminates the release of metallic corrosion particulates into the joint space, which can be found when cobalt chromium alloy heads are mounted onto cobalt chromium alloy femoral stems. These ceramic modular heads are designed for use with cobalt chromium alloy femoral hip stems manufactured by Corin Medical.

Sub-contract manufacture of Corin Medical's Zirconia Ceramic Modular Heads is performed by Morgan Matroc Ltd, St Peter's Road, Rugby, Warwickshire, CV21 3QR, Eingland.

Morgan Matroc Ltd's master file held by the FDA is reference number MAF-343.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle in flight, with three stripes representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 2 3 1999

Mr. Craig Corrance President Corin U.S.A. 10500 University Center Drive, Suite 190 Tampa, Florida 33612

K992235 Re: Zyranox™ Zirconia Ceramic Femoral Heads Trade Name: Regulatory Class: II Product Code: LZO Dated: September 15, 1999 Received: "September 24, 1999

## Dear Mr. Corrance:

We have reviewed your Section 510(k) notification of intent to we have levice your boosies. bove and we have determined the market the device forcechood above indications for device 13 substancially ogal to devices marketed in interstate use stated in the chorobats) is the enactment date of the Commerce prior co naj ents, or to devices that have been Medical Device Amendico, or of to be provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, rood, blug, and coometre not (the, coneral controls provisions The general controls provisions of the Act of the Act. of the Act. The general ovnual registration, listing of Incrade requirementacturing practice, labeling, and devices, good manast misbranding and adulteration.

If your device is classified (see above) into either class II II your device 15 crass III (Premarket Approval), it may (Special Concrolo) additional controls. Existing major be subject to such addrois device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ત્ત્વ rederal Regulations) freis tirmination assumes compliance with Subscancially oqualize Practice requirement, as set Ene Current Quality System Regulation (QS) for Medical Forth in the Quarry System on J. CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug enrough porious (FDA) will verify such assumptions. Failure to Administration (FBF) regulation may result in regulatory Comply with the GMF rogan may publish further announcements concerning your device in the Federal Register. Please note: concerning your device remarket notification submission does ents response obligation you might have under sections 531 through 542 of the Act for devices under the Electronic chrough 542 or the new reregulations.

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Page 2 - Mr. Craig Corrance

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neil R.P. Oghan for
James E. Dillard III

Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Kadiological Health

Enclosure

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Page ***_*** of **_**

510(k) Number (if known): K992235-

Device Name: Zysanox Zisconna Cesance Fremond Heads

## INDICATIONS FOR USE

The Zirconia Ceramic Modular Heads are used in combination with femoral hip stems and ultra high molecular weight polychylene (UHMWPE) acetabular cups or acetabular cups or acetabular cups or acetabular cup liners to reinstate function following the degenerative effects of osteo or rheumatoid arthritis, post-trauma disease effects, avascular necrosis and septic or aseptic total hip revision.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

for
(Division Sign-Off)
Division of General Restorative Devices K992235
510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use No

(Optional Format 1-2-96)