All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, 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 ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

AcuMatch® P-Series and AcuMatch® L-Series press-fit femoral stems are intended for press-fit fixation.

Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.

Device Description

AcuMatch 12/14 Press-Fit femoral stems are composed of titanium alloy (ASTM F1472), have a trapezoidal cross-sectional geometry and distal taper.

12/14 P-Series model has a plasma-spray surface enhancement.
12/14 L-Series model has a corundum finish.

Both models have a hydroxyapatite (HA) coating option. The femoral stems are intended for press-fit fixation. Models without the HA coating may be used with bone cement at the discretion of the surgeon.

AI/ML Overview

I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) summary for a medical device (Exactech AcuMatch 12/14 Press-Fit Femoral Stems) and focuses on establishing substantial equivalence to a predicate device. It does not contain information about specific performance acceptance criteria, study designs to prove meeting those criteria, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for such studies.

The document states that the conclusion drawn from empirical testing and engineering analyses is that the components would be adequate for anticipated in vivo use, and that this leads to the conclusion of substantial equivalence. However, it does not detail the specific acceptance criteria or the study designs and results used to arrive at this conclusion.

Summary

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Exactech

JUN 2 1 2005

FL 32653

FAX 352-378-2617

Exactech® AcuMatch 12/14 Press-Fit Femoral Stems

510(k) Summary of Safety and Effectiveness Special 510(k)

Trade or proprietary or model name(s):

AcuMatch 12/14 P-Series Press-Fit Plasma Femoral Stems AcuMatch 12/14 L-Series Press-Fit Femoral Stems

Information on devices to which substantial equivalence is claimed:

510(k)	Trade or Proprietary or Model Name	Manufacturer
NumberK041906	AcuMatch 12/14 P-Series Plasma Press-Fit Femoral StemsAcuMatch 12/14 L-Series Press-Fit Femoral Stems	Exactech, Inc

INDICATIONS

AcuMatch® P-Series and AcuMatch® L-Series press-fit femoral stems are intended for press-fit fixation.

Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.

Special 510(k) Modifications

The AcuMatch 12/14 Press-Fit femoral stems were modified from the predicate as follows:

The geometry of the insertion hole feature was modified from an oblong slot to an . oblong slot with threads (P-Series only).
The tolerance of the 12/14 taper threadform geometry was expanded. .
Collared 12/14 P-Series Press-Fit Stem option was added. .

Rev. 05/19/05

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Exactech

Image /page/1/Picture/1 description: The image shows an address written in cursive and print. The address is "Kari 1335 2320 NW 66TH COURT GAINESVILLE, FL 32653". The first line is written in cursive, while the rest of the address is printed.

FAX 352-378-2617

Exactech® AcuMatch 12/14 Press-Fit Femoral Stems

510(k) Summary of Safety and Effectiveness Special 510(k)

AcuMatch 12/14 Press-Fit Femoral Stems

AcuMatch 12/14 Press-Fit femoral stems are composed of titanium alloy (ASTM F1472), have a trapezoidal cross-sectional geometry and distal taper.

12/14 P-Series model has a plasma-spray surface enhancement. ●
12/14 L-Series model has a corundum finish. .

Both models have a hydroxyapatite (HA) coating option. The femoral stems are intended Doth models have a try are models without the HA coating may be used with bone cement at the discretion of the surgeon.

Conclusion:

Conclusion." results one clightering - 12:14 Press-Fit Femoral Stem components would be adequate for anticipated in vivo use. This includes empirical testing and engineering analyses. Based on successful results we conclude that the proposed devices are substantially equivalent to Exactech's predicate femoral stems.

Rev. 05/19/05

Section 4 Page 3 of 3

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized eagle emblem. The eagle is depicted with three lines forming its head and wings, giving it a modern and abstract appearance.

JUN 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Maritza Elias Regulatory Representative Exactech, Inc. 2320 N.W. 66th Court Gainesville, Florida 32653

Re: K051335

Trade/Device Name: Exactech Acumatch 12/14 Press-Fit Femoral Stems Regulation Number: 21 CFR 888.3353, 888.3350 Regulation Name: Hip joint metal/cemented/polymer semi-constrained cemented or nonregaration Names - Hip joint metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JDI, LWJ, MEH, LZO Dated: May 17, 2005 Received: May 23, 2005

Dear Ms. Elias:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for doo based or 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou mayy atch s 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 (PMA), it rr your de rise to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal 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 r that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 – Ms. Maritza Elias

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (seting your device as described in your Section 510(k) This letter will anow you to oegin mains of substantial equivalence of your device to a legally premarket notheadon. The PDF mining sitems of 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 acriously at (240) 276-0120. Also, please note the regulation entitled, Comaci the Office of Comphanes and in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation en Journer 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,

Miriam C. Provost

Miriam C. Provost, Ph.D. 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.

Exactech AcuMatch 12/14 Press-Fit Femoral Stems

Indications for Use

K051335 510(k) Number:

INDICATIONS

INDICATIONS
All Exactech Hip Systems are indicated for use in skeletally mature individuals All Exactech Hip Systems are more to ass them to osteon thritis, the matoid
undergoing primary surgery for hip replacement due to steem of the hin, and for undergoing primary surgely for mp replacement we problems of the hip, and for arthritis, osteonecrosis, post-tradinatio copines where prosthetic replacement is determined by treatment of proximal remoral fractures when provins of Exactech Hip Systems are also
the surgeon as the preferred treatment. Components hip dysplassia, revision of the surgeon as the preletted treatinent. Configure on tall hip dysplass, revision of
potentially indicated for ankylosing spondylitis, congent, and to restore potentially indicated for allRylosing spondyinia, occaged is present, and to restore mobility resulting from previous fusion.

AcuMatch® P-Series and AcuMatch® L-Series press-fit femoral stems are intended for press-fit fixation.

Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.

Prescription Use

Over the Counter Use _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Section 3 Page 1 of 1

05/18/05

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

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