AcuMatch® A-Series Enhanced Polyethylene Acetabular Liners are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.

Device Description

This Special 510(k) premarket notification describes a material change from the predicate AcuMatch® A-Series UHMWPE polyethylene acetabular liners to acetabular liners manufactured from Enhanced Polyethylene. Additionally 5 new sizes are being introduced to the A-Series system.

AI/ML Overview

The provided document, K051556, pertains to a medical device submission for the Exactech® AcuMatch® A-Series Enhanced Polyethylene Acetabular Liner. This is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and performance studies for a novel device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets them in the context of an AI/algorithm-driven medical device.

Specifically, the document describes:

A material change for an existing acetabular liner and the introduction of new sizes.
The device description, intended use, and contraindications.
Legally marketed predicate devices to which the new device is compared for substantial equivalence.
The FDA's decision regarding substantial equivalence.

It does not include:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance, or details about retrospective/prospective studies.
Number or qualifications of experts used to establish ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone (algorithm-only) performance studies.
Type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

These types of details are typically found in submissions for novel AI/ML-driven medical devices or those requiring de novo classification or PMA applications, which involve rigorous clinical performance evaluations against predefined statistical endpoints. This document, being a 510(k) for a material and size change, relies on demonstrating that the modified device is as safe and effective as a legally marketed predicate device, primarily through non-clinical (e.g., mechanical testing) comparisons, rather than human-reader performance studies.

Summary

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K051556 p1/3

SEP - 6 2005

Summary of Safety and Effectiveness

Exactech® AcuMatch® A-Series Enhanced Polyethylene Acetabular Liner

Sponsor:	Exactech® Inc.2320 N.W. 66th CourtGainesville, Florida 32653
Phone:	(352) - 377 - 1140
Fax:	(352) - 378 - 2617
FDA Establishment #:	1038671
Contact:	Diana TaylorRegulatory Representative
Date:	August 26, 2005
Trade Name:	Exactech® AcuMatch® A-Series Connexion GXLEnhanced UHMWPE Acetabular Liner
Common Name:	Total Hip Prosthesis Acetabular Component

Device Description:	Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis	C.F.R.	888.3358
Product Code:	LPH	Section
Device Description:	Hip joint metal/polymer semi-constrained cemented prosthesis	C.F.R.	888.3350
Product Code:	JDI	Section
Device Description:	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis	C.F.R.	888.3353
Product Code:	MEH	Section
Device Description:	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis	C.F.R.	888.3353
Product Code:	LZO	Section
Device Description:	Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis	C.F.R.	888.3360
Product Code:	LWJ	Section

Section 4
Page 1 of 3

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Summary of Safety and Effectiveness

Exactech® AcuMatch® A-Series Enhanced Polyethylene Acetabular Liner

Intended Use / Indications:

Contraindications:

AcuMatch® A-Series Enhanced Polyethylene Acetabular liners are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the system.

Description:

Packaging and Sterilization:

AcuMatch® A-Series Enhanced UHMWPE Acetabular Iiners are sealed in two Tyvek® pouches. The pouches are enclosed in a poly bag and placed into the outer carton. A tamper-resistant seals on the outer box contain the statement "sterile unless seal is broken". An outer product label is attached to the outer carton. The carton is then shrink-wrapped.

Products are terminally sterilized by a precision gamma irradiation dose of 25.2 - 30.8 kGy. The Sterility Assurance Level (SAL) is 10°.

Section 4 Page 2 of 3

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Summary of Safety and Effectiveness

Exactech® AcuMatch® A-Series Enhanced Polyethylene Acetabular Liner

Legally Marketed Predicate Devices

Model	Manufacturer	510(k) #	ClearanceDate	ProductCode(s)
AcuMatch® A-Series PorousCoated AcetabularComponent	Exactech	K993082	11/19/1999	LPH & JDI
AcuMatch® A-Series andMCS Acetabular Shells &Liners	Exactech	K040613	06/4/2004	JDI, LPH &MEH
AcuMatch® A-Series 36mmAcetabular Liner, 12/14Femoral Head and Press-FitFemoral Stems	Exactech	K041906	09/10/2004	LPH, LZO,MEH, LWJ& JDI

Conclusion:

The proposed AcuMatch® A-Series Enhanced Polyethylene Acetabular Liners are substantially equivalent to the predicate AcuMatch® A-Series Acetabular Liners of the same design, which have not had additional processing of the material. The proposed liners manufactured from enhanced material are expected to exhibit reduced wear, while maintaining suitable mechanical and physical properties.

Section 4 Page 3 of 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2005

Ms. Diana Taylor Manager, Regulatory Affairs Exactech®, Inc. 2320 N.W. 66th Court Gainesville, Florida 32653

Re: K051556 Trade/Device Name: AcuMatch® A-Series Enhanced Polyethylene Acetabular Liners Regulation Number: 21 CFR 888.3358, 21 CFR 888.3350, 21 CFR 888.3353, 21 CFR 888.3360 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Hip joint metal/polymer semi-constrained cemented prosthesis, Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. Regulatory Class: II Product Code: LPH, JDI, LZO, MEH, LWJ Dated: August 09, 2005 Received: August 10, 2005

Dear Ms. Taylor:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your corrent for the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to econimer to may 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). and Cosmetic Pror (110) that to device, subject to the general controls provisions of the Act. The I va may, dierely mains 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 may be subject to suen addrents regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Ms. Diana Taylor

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuated of a budenian and other requirements of the Act ulat IDA has made a decormination and Journer Federal agencies. You must of ally if ederal statutes and regulations and limited to: registration and listing (21 comply will an the 11ct 5 requirements, as a manufacturing practice requirements as set CTN Fart 607), adomig (21 OFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 halkening of substantial equivalence of your device to a legally premarket nothleadon: "The PDF misms sification 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 If you desire specific acritorior your as not 100 100 - Also, please note the regulation entitled, Comaci the Office of Compilance and (21CFR Part 807.97). You may obtain Misoraliding by releveloc to premainter withilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

signature

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

Enclosure

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Exactech®, Inc.

AcuMatch® A-Series Enhanced Polyethylene Acetabular Liners

Indications for Use

510(k) Number:

Kossrlo

Device Name: AcuMatch® A-Series Enhanced Polyethylene Acetabular Liners

Indications for Use:

Contraindications:

Prescription Use	X	or	Over the Counter Use
------------------	---	----	----------------------	--

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

510(k) Number	K051556
	Section 3 Page 1 of 1

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
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.(b)
Classification. Class II.