CUSTOM FLANGED ACETABULAR COMPONENT

K983035 · Biomet, Inc. · LPH · Nov 23, 1998 · Orthopedic

Device Facts

• Record ID: K983035
• Device Name: CUSTOM FLANGED ACETABULAR COMPONENT
• Applicant: Biomet, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Nov 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Patient Matched Flanged Acetabular Component is indicated for use in patients requiring reconstruction of the hip ioint due to disease, deformity or trauma. The device is intended for either cernentless application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. The device is a single use implant. The device is to be used in conjunction with Biomet's RingLoo® Acetabular Liners. The device may be used in conjunction with any commercially available femoral component.

Device Story

Patient Matched Flanged Acetabular Component is a custom-manufactured acetabular cup designed to match individual patient hip geometry. Device is a single-use implant used in hip reconstruction surgery. It is intended for use with Biomet RingLock Acetabular Liners and is compatible with commercially available femoral components. The device is implanted by orthopedic surgeons in a clinical/hospital setting. By matching the patient's natural anatomy, the device aims to facilitate hip joint rehabilitation following disease, deformity, or trauma. Clinical decision-making relies on the surgeon's assessment of the patient's specific anatomical needs, which informs the custom design of the component.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Acetabular cup implant; patient-matched geometry; intended for cemented or cementless application; single-use. Materials and specific standards not detailed in provided text.

Indications for Use

Indicated for skeletally mature patients requiring hip joint reconstruction due to disease, deformity, or trauma. Intended for cemented or cementless application for hip joint rehabilitation. Single-use implant.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Healeym Revision Acetabular Component
• Recovery Protusio Cage
• Universal® Acetabular Component
• Mallory-Head® Acetabular Component

Submission Summary (Full Text)

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NOV 2 3 1998

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## Summary of Safety and Effectiveness

Biomet, Inc. Sponsor: Airport Industrial Park Warsaw. Indiana 46580

Device Name: Patient Matched Flanged Acetabular Component

Classification Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis (888,3358) and Hip joint metal/polymer semi-constrained cemented prosthesis (888,3350)

Intended Use: The Patient Matched Flanged Acetabular Component is indicated for use in patients requiring reconstruction of the hip ioint due to disease, deformity or trauma. The device is intended for either cernentless application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. The device is a single use implant. The device is to be used in conjunction with Biomet's RingLoo® Acetabular Liners. The device may be used in conjunction with any commercially available femoral component.

Device Description: The Patient Matched Flanged Acetabular Component is an acetabular cup designed to match the natural geometry of an individual patient Matched Flanged Acefabular Component is matched to a particular patient, a specific device description is not possible.

Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:

Reaction to the bone cement Deformity of the joint Cardiovascular disorders Fracture of the cement Implant loosening/mioration Breakdown of the porous surface

Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Tissue growth failure

Bone fracture Infection Hematoma Dislocation Excessive wear Nerve damage

Substantial Equivalence: The Patient Matched Flanged Acetabular Component is substantially equivalent to almost all acetabular devices on the market in overall design and intended function. Predicate devices include:

> Healeym Revision Acetabular Component Recovery Protusio Cage Universal® Acetabular Component Mallory-Head® Acetabular Component

MAILING ADDRESS 1,0. Box 587 Warsaw. IN 46581-0587

SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580

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OFFICE 219,267.6639

ドヘン 219.267.8137

E-MAIL גווגווגוווגוווווווווווווווו

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 1998

Ms. Patricia S. Beres Senior Regulatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana

Re: K983035 Patient Matched Flanged Acetabular Component Trade Name: Regulatory Class: II Product Codes: LPH and JDI Dated: August 27, 1998 August 31, 1998 Received:

Dear Ms. Beres:

We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Ms. Patricia S. Beres

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 markees problems, 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 compriation and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to ene royal 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,

Celia M. Witten, Ph.D., M.D.
Director

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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51.0 (k) Number (if known): k 983035

Device Name: Patient Matched Flanged Acetabular Component

0219 372 1790

Indications For Use:

Flanged Acetabular Component is indicated for use in patients The Patient Matched requiring reconstruction of the hip joint due to disease, deformity or trauma. The device is intended for either cemented or cementless application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip The joints. device is a single use implant. The device is to be used in conjunction with Biomet's The device may be used in conjunction with any commercially RingLock Acetabular Liners. available femoral component.

BIOMET ACC/LEGAL

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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)

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