patient conditions of noninflammatory degenerative joint disease (NIDD), e.g., rheumatoid arthritis;
Those patients with failed previous surgery where pain, deformity, or dysfunction persists;
Revision of previously failed hip arthroplasty.

Device Description

The Alpha Metasul Acetabular Insert (28mm and 32mm) is a hemispherically shaped design, composed of an outer component manufactured from ultra-high molecular weight polyethylene (UHMWPE) thermo-mechanically bonded to a wrought hot-forged CoCr alloy metallic inlay (in compliance with ISO 5832-12 and ASTM F1537). The Alpha Metasul Acetabular Insert is designed for use only with a Metasul femoral head. The Alpha Metasul Acetabular Insert is a metal-on-metal component, metal surfaces.

The Alpha Metasul 32mm Acetabular Insert, both standard and hooded, is available in sizes 52mm to 68mm (in 2mm increments). In turn, the proposed Alpha Metasul 32mm Acetabular Inserts are designed to mate with Allofit™ Acetabular Shells, sizes 48mm to 68mm (in 2mm increments). Both insert sizes mate the same basic design as the previously cleared Alpha Metasul 28mm Acetabular Insert and share many features with the Ringloc® Acetabular Liner and M2a -Taper Acetabular System.

The Alpha Metasul Insert has what is commonly referred to as a "poly-sandwich" design. The bearing surface of the insert, features a metallic Metasul inlay that is polished to a mirror-finish and themo-mechanically bonded into the proven polyethylene liner, which is then locked into the Allofit acetabular shell via a blocked in snap mechanism. On the hooded inserts, the face of this polyethylene liner incorporates an overhang of polyethylene extending beyond the midpoint of the metallic inlay to help prevent subluxation and instability.

AI/ML Overview

This device is a Class III medical device, however, the provided documentation does not contain a study that proves the device meets specific acceptance criteria.

The document is a 510(k) Premarket Notification for the Alpha Metasul 28mm and 32mm Acetabular Inserts. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving efficacy or meeting specific performance acceptance criteria through a clinical study.

The "BASIS OF SUBSTANTIAL EQUIVALENCE" section states: "Performance tests, design comparisons, indications for use and labeling of the Alpha Metasul 28mm and 32mm Acetabular Inserts (Standard and hooded) demonstrations equivalent materials, designs, and indications for use to the predicate devices." This suggests that the submission relied on demonstrating similarity to already approved devices, rather than presenting novel performance data against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the provided text.

Summary

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K03 3943

OCT 1 8 2004

510(k) Premarket Notification 510(k) Prematiet Notification
Alpha Metasul 28mm and 32mm Acetabular Inserts, Standard and Hooded

510(k) SUMMARY

MANUFACTURER:	Centerpulse Orthopedics, Ltd. (a division of Zimmer)Altgasse 44CH-6340Baar, Switzerland
SPONSOR:	Centerpulse Orthopedics, Inc. (a division of Zimmer)9900 Spectrum DriveAustin, TX 78717 USA
CONTACT:	Audrey SwearingenPhone: (512) 432-9255E-Mail: Audrey.Swearingen@zimmer.com
TRADE NAME:	Alpha Metasul® 28mm and 32mm Acetabular Inserts,Standard and Hooded
COMMON NAME:	Total hip replacement system acetabular insert
CLASSIFICATION:	CFR §888.3330 (KWA) - Hip joint metal/metalsemiconstrained, with an uncemented acetabularcomponent, prosthesis. Metal-on-metal hip prostheses arePreamendment Class III devices.

PREDICATE DEVICES:

EDICATE DEVIOEG.
Centerpulse Orthopedics Inc. Allofit™ Acetabular System, Alpha Metasul® Acetabular . Insert, 28mm Standard and Hooded (K003758)
Insert, 202a™ Ringloc® Acetabular Liner (K002379) .
Biomet M2a -Taper™ Acetabular System (K003363) .

DEVICE DESCRIPTION:

DEVICE DESCRIP TION.
The Alpha Metasul Acetabular Insert (28mm and 32mm) is a hemispherically Shaped The Alpha Metasur Acelabular Insert (Echnif and Game) polyethylene (UHMWFE)
design, composed of an outer component manufactured from polyethylene a wrought design, composed of an outer component intermo-mechanically bonded to a wrought (in compliance with TOO 503+ II2) which with ISO 5832-12 and ASTM F1537).
hot-forged CoCr alloy metallic inlay (in compliance with ISO 5832-12 and Associations not-forged CoCr alloy metalle intay (in complianter rise only with a Metasul femoral head.
The Alpha Metasul Acetabular Insert is designed for use only with a Metasul the The Alpha Metasur Acelabular Insolt is a signed for ass one on the many of the component, metal surfaces.

The Alpha Metasul 32mm Acetabular Insert, both standard and hooded, is available in The Alpha Metasur Szhm? Acetabular Shells, sizes 52mm to 68mm to 68mm (in 2mm sizes designed to mate with Allolle - Acctubular Choile, Case enning available in sizes Increments). In turn, the proposed Alpha Motabular Shells, sizes 48mm to 68mm (in 2mm designed to 'mate 'with 'Allen'' 'Allell' - 'Ale same basic design as the previously cleared Alpha increments). Dour insert sizes nate the sand hooded. They also share many Metasur 2011n1 710ctubular Though Scetabular Liner and M2a -Taper Acetabular System.

The Alpha Metasul Insert has what is commonly referred to as a "poly-sandwich" design. The Alpha Mccasur noon has mathe bearing surface of the insert, features a metallic

{1}------------------------------------------------

510(k) Premarket Notification 510(k) Premarket Notification
Alpha Metasul 28mm and 32mm Acetabular Inserts, Standard and Hooded

Metasul inlay that is polished to a mirror-finish and themo-mechanically bonded into the proven Metasul inlay that is polished to a mirror-ining the Allofit acetabular shell was aroven
polyethylene liner, which is then locked into the Alloft access of the proven polyethylene liner, which is then tocked into his blocked in snap mechanism. On the nooded inserts, the face of this por the midpoint of the incorporates an overnang of polyethylene extending ouponally would be and the subluxation and instability.

INTENDED USE:

INTENDED USE:
The Alpha Metasul 28mm and 32mm Acetabular Inserts, standard and hooded, are The Alpha Tivetasur Zomin' arthroplasty for treatment of the following:

Patient conditions of noninflammatory degenerative joint disease (NID), e.g., . Patient conditions of nominiatimatory dogenorative joint disease (IJD), e.g., rheumatoid arthritis;
Those patients with failed previous surgery where pain, deformity, or dysfunction . persists;
Revision of previously failed hip arthroplasty. .

BASIS OF SUBSTANTIAL EQUIVALENCE:

BASIS OF SUBSTANTIAL EQUIVALL, 102.
Performance tests, design comparisons, indications for use and labeling of the Alpha Performance lests, design compansens, indications and hooded) demonstrations Metasul 2011n and SZHIN Acelabular insorts (StanLard unes, materials, and indications for use to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above three wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2004

Ms. Audrey Swearingen Manager, Regulatory Affairs Zimmer, Inc. 9900 Spectrum Drive Austin, Texas 78717

Re: K033943

K035743
Trade/Device Name: Alpha™ Metasul® 28mm and 32mm Acetabular Insert Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA Dated: September 24, 2004 Received: September 27, 2004

Dear Ms. Swearingen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) perceise is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars annount date of the Medical Device Amendments, or to commence provision to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been recure approval of a premarket approval application (PMA). and Cosmetic Acr (Free) market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of gencral controls provisions 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 If your device is classified (600 a00 royals. Existing major regulations affecting your device can may be subject to saterial 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 Frease oc advised that 1271 3 ibsuance or our device complies with other requirements of the Act that i DA has made a determinations administered by other Federal agencies. You must or any I cacial statutes and regulations, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 607), adomig (21 OFR 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. Audrey Swearingen

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manceling your antial equivalence of your device to a legally premarket nothication. THC PDA midning of cacomman s p.
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 Patt 801), please If you desire specific advice for your act 100 case. Also, please note the regulation entitled, Conliact the Office of Complance at (3 of Critication" (21CFR Part 807.97). You may obtain "Misbranding by reference to premarket icolifical vir the Act from the Division of Small other general information on your responsible in the toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Melberer

Celia 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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Indications for Use

K033943 510(k) Number (if known):

Alpha™ Metasul® 28mm and 32mm Acetabular Insert Device Name:

Indications for Use:

The Alpha™ Metasul® Acetabular Insert is intended for use in total hip arthroplasty for treatment of the following:

patient conditions of noninflammatory degenerative joint disease (NIDD), e.g., , . patient conditions of nominationatory cogstern of the matory joint disease (IJD), e.g., rheumatoid arthritis;
rheumatolu arthritis, . persists;
revision of previously failed hip arthroplasty. .

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

K033943

Mark N. Mallem

Restorative, Jeurological Devices

Page __ of____________________________________________________________________________________________________________________________________________________________________

(Posted November 13, 2003)

510(k) Number

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.