PAR 5 ACETABULAR COMPONENT

K000254 · Biomet, Inc. · JDI · Feb 7, 2000 · Orthopedic

Device Facts

• Record ID: K000254
• Device Name: PAR 5 ACETABULAR COMPONENT
• Applicant: Biomet, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Feb 7, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The indications for the Par 5 Acetabular Component are as follows: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Treatment of nonunion, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques 5) Revision of failed total joint construction or treatment

Device Story

Par 5 Acetabular Component is a hemispherical metallic acetabular cup used in total hip arthroplasty. Device features a shell with six screw holes for 6.5mm cancellous screws, three counterbores for attachment of hook and blade components, and a mounting flange for an ilium flange. Components include a malleable ilium flange (small, medium, large; left/right/straight), a malleable hook for ischium teardrop placement, and a blade component for ischium bone entry. Surgeon shapes malleable components to patient anatomy to provide additional support. Shell accepts standard Biomet Ring-loc liner. Device is implanted by orthopedic surgeons in a clinical/OR setting. Provides structural support and fixation for hip joint reconstruction; benefits patient by restoring joint function and stability in cases of degenerative disease, fracture, or revision.

Clinical Evidence

Bench testing only.

Technological Characteristics

Hemispherical acetabular cup; materials: CP titanium (ilium flange, hook) and titanium alloy Ti-6Al-4V (cup, blade) per ASTM F-136; outer shell surface features titanium plasma spray; modular components include malleable ilium flange, hook, and blade; accepts standard Ring-loc liner; fixation via 6.5mm cancellous screws.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal femur fractures (nonunion, femoral neck, trochanteric) requiring head involvement, or revision of failed total joint construction.

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).

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS

Sponsor: Biomet, Inc.

Contact Person: Patricia Sandborn Beres

Trade Name: Par 5 Acetabular Component

Classification Name: Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR 8883350)

## Indications for Use:

- for Use:
Noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis
- Rheumatoid arthritis 2)
- Correction of functional deformity 3)
- Correction of functional delomity
Treatment of nonunion, femoral neck fractures, and throchanteric fractures of the 4) i reatment of nonunion, femoral neon nactaros, and the sing other techniques
- proximal remar with neath joint construction or treatment 5)

Device Description: The Par 5 Acetabular Component is a hemispherical metallic acetabular Device Description: The Par 5 Aceladular Oomponent on rim. The shell has six
cup with a hook, flange and/or blade extending from the contabular component. cup with a hook, flange and/or blace extending to a traditional acetabular component.
holes for placement of 6.5mm cancellous screws similar to a traditional and blade compon holes for placement of 6.5mm carcellous screws simman of the hook and blade components
Additionally, the shell has three counterbores for attachment of the hook a standard Hi Additionally, the shell has three counterbores for attachment of the illustian and Biomet
and a mounting flange for attachment of the ilium flange. The shell accepts a stand Ring-loc liner.

The forked illum flange is available in three sizes: small, medium and large and in left, right and in The forked illum frange is available in three stace. Smally houldned to the flange is a straight configurations. Screw noles and more of the sheaped the patient's malleable and can be shaped by the surgeon in the will on the shall of the shall at the mounting
anatomy to provide additional support. The ilium flange is attached to the m flange by the component geometry and screw fasteners.

The malleable hook is placed within one of the counterbores of the shell in a position where it will The malleable nook is placed within one of the outler of the one of the one
reside beneath the teardrop of the ishium. The hook is formed to the patient's anatomy by the reside benefit is held to the shell by a screw.

The blade component is intended to enter the ishium bone in a manner similar to a sceve. The she The blade component is mended to enter the ishis not of this component is held to the shell
curvature of the blade resembles the curvature of the component is held to the she curvature of the blade roosmbles the out secondarily, by a screw.

The illum flange and hook are fabricated from commercially pure (CP) titanium. The cup and The illum flange and hook are fabricated from tommontally por (e. 7) P. (e. 7) F-136. The outer
blade are fabricated from titanium alloy (Ti-6Al-4) conformances blade are labhoutou from the shell with titanium plasma spray.

> MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

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SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580

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OFFICE 219.267.6639

**FAX**
219.267.8137

E-MAIL [e-mail]

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Potential Risks: The potential risks associated with this device are the same as with any other total 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/migration Break down of the porous surface Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the component Excessive wear

Bone fracture Infection Hematoma Dislocation Nerve damage

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2000 FEB

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

Re: K000254

Trade Name: PAR 5 Acetabluar Component Regulatory Class: II Product Code: JDI Dated: January 27, 2000 Received: January 28, 2000

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 above and we have assemment in interstate commerce prior to May 28, 1976, the stated in the encreater) to the Medical Device Amendments, or to devices that have been reclassified in eccordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 action. In addition, FDA may publish further announcements 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.

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.

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### Page 2 - Ms. Patricia Sandborn Beres

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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Russell Sayre
E. Dill, III

Sames E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloģical Health

Enclosure

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510(k) Number (if known): KOOOZ SY

Device Name: Par 5 Acetabular Component

#### Indications For Use:

The indications for the Par 5 Acetabular Component are as follows:

- 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- 2) Rheumatoid arthritis
- 3) Correction of functional deformity
- 4) Treatment of nonunion, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
- 5) Revision of failed total joint construction or treatment

(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 Devices K 900259 510(k) Number

Prescription Use
X
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

00007