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.

Cemented femoral stems and cemented acetabular cups are intended for . cemented fixation only.
Press-fit femoral stems and acetabular cups 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.
Femoral heads and endoprostheses are intended for use in cemented and . press-fit applications.

Device Description

Not Found

AI/ML Overview

This device is a modified version of previously cleared devices (AcuMatch 12/14 C-Series Cemented Femoral Stems, AcuMatch 12/14 L-Series Cemented Femoral Stems, and Novation Cemented Femoral Stems). The nature of the modifications are changes to geometry, dimensions, and material specifications for some components.

Therefore, the study performed to demonstrate that the device meets acceptance criteria is based on engineering evaluations and empirical testing to verify performance, rather than clinical trials with human readers or standalone algorithm performance.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Functional Equivalence	The modified device must perform adequately for anticipated in vivo use and maintain substantial equivalence to the predicate devices.	"Testing and engineering evaluations were conducted to verify that the performance of the new Exactech AcuMatch 12/14 Cemented Femoral Stems and Novation Cemented Stems 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."
Biocompatibility	(Not explicitly stated, but implied for medical devices with material changes) The materials must be biocompatible for human implantation.	The L-Series cemented stem material was changed from cast Co-28Cr-6Mo (ASTM F75) to forged Co-28Cr-6Mo (ASTM F799). Both ASTM F75 and ASTM F799 are widely accepted biocompatible materials for orthopaedic implants. The submission likely included documentation demonstrating the new material's compliance with ISO/ASTM standards for medical implant materials, which would inherently include biocompatibility testing (although not detailed in this summary).
Mechanical Integrity	Devices must withstand anticipated in vivo mechanical stresses and maintain structural integrity.	"Testing and engineering evaluations were conducted to verify that the performance... would be adequate for anticipated in vivo use. This includes empirical testing and engineering analyses." While specific tests (e.g., fatigue, static strength, push-out tests for cemented stems) are not detailed, these are standard tests for orthopaedic implants undergoing geometric or material changes. The "successful results" indicate these tests confirmed the device's mechanical integrity.
Fit and Taper Compatibility	The new 12/14 Euro-Style taper must be compatible with existing femoral heads.	"The femoral head/neck taper geometry was modified from Exactech's proprietary taper design to the '12/14 Euro-Style' threadform taper design." This modification would have required testing to ensure proper mating with standard 12/14 Euro-Style femoral heads, including tests for seating, rocking, and potential fretting-corrosion. The "successful results" imply these aspects were verified and met predefined specifications ensuring proper articulation with compatible components.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The study involved "empirical testing and engineering analyses" which typically refers to samples of the device itself (e.g., a certain number of each stem configuration to undergo mechanical testing) rather than a human patient test set.
Data Provenance: Not explicitly stated, but the nature of the study (engineering evaluations) implies it was internal laboratory testing, likely conducted at Exactech facilities or by contract testing labs. There is no indication of human patient data or country of origin for such data. This is a retrospective analysis in the sense that no new clinical data from patients was gathered; it relied on existing engineering principles and physical testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of study does not involve "experts" in the context of establishing ground truth for diagnostic accuracy (e.g., radiologists interpreting images). The "ground truth" for engineering evaluations is established by engineering specifications, industry standards (e.g., ASTM, ISO), and regulatory requirements. The "experts" involved would be design engineers, material scientists, and quality engineers who define these specifications and interpret test results against them. Their qualifications would be in their respective engineering fields.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data. For engineering tests, results are judged against predetermined pass/fail criteria derived from standards or validated computational models.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an orthopedic implant, not a diagnostic AI tool. No MRMC study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this 510(k) submission, the "ground truth" relies on:
- Engineering Specifications and Standards: Adherence to established ASTM/ISO standards for material properties and mechanical performance.
- Predicate Device Performance: The primary ground truth is the established safe and effective performance of the predicate devices. The modifications must not adversely affect this equivalence.
- Regulatory Requirements: Compliance with FDA regulations for medical devices.

8. The Sample Size for the Training Set

Not applicable in the context of an engineering evaluation for an orthopedic implant. There is no concept of a "training set" as there would be for an AI algorithm. The device design and manufacturing processes are developed based on extensive engineering knowledge and prior product experience, but not a "training set" in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the reasons stated in point 8.

Summary

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DEC 2 7 2005

2320 NW 66TH COURT GAINESVILLE, FL 32653

352 377-1140 FAX 352-378-2617

K052787

Exactech® Inc. AcuMatch 12/14 Cemented Femoral Stems Novation 12/14 Cemented Femoral Stems 510(k) Summary of Safety and Effectiveness Special 510(k)

Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653

Phone:	(352) - 377 - 1140
Fax:	(352) - 378 - 2617

FDA Establishment Number 1038671

Bennie Gladdish Contact: Hip Systems Manager/Principal Engineer

Date: September 27, 2005

Rev. 09/27/05

Section 4 Page 1 of 3

EXACTCH eight to inprove the politions by minibiling their octive ond integendence. We do this though innotive ides, high-quoting reduction on commitment to sense.

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352 377-1140 FAX 352-378-2617

Exactech® Inc. AcuMatch 12/14 Cemented Femoral Stems Novation 12/14 Cemented Femoral Stems 510(k) Summary of Safety and Effectiveness Special 510(k)

Trade or proprietary or model name(s):

AcuMatch 12/14 C-Series Cemented Femoral Stems (Size 1-6) AcuMatch 12/14 L-Series Cemented Femoral Stems (Size 1-5) Novation Cemented Femoral Stems (Size 9,11,13,15,17)

Information on devices to which substantial equivalence is claimed:

510(k)	Trade or Proprietary or Model Name	Manufacturer
Number
K023646	AcuMatch 12/14 C-Series Cemented Femoral Stems (Size 1-6)	Exactech, Inc.
K001335	AcuMatch 12/14 L-Series Cemented Femoral Stems (Size 2-5)
K011218	AcuMatch 12/14 L-Series Cemented Femoral Stems (Size 1 )

INDICATIONS

Cemented femoral stems and cemented acetabular cups are intended for . cemented fixation only.
Press-fit femoral stems and acetabular cups 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.
Femoral heads and endoprostheses are intended for use in cemented and . press-fit applications.

Special 510(k) Modifications

The AcuMatch 12/14 C-Series Cemented femoral stems were modified from the predicate as follows:

The femoral head/neck taper geometry was modified from Exactech's proprietary ● taper design to the "12/14 Euro-Style" threadform taper design
Rev. 09/27/05

Section 4 Page 2 of 3

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352-377 1140 FAX 352-378-2617

Exactech® Inc.

AcuMatch 12/14 Cemented Femoral Stems Novation 12/14 Cemented Femoral Stems 510(k) Summary of Safety and Effectiveness

Special 510(k)

The femoral neck length was decreased by 4mm .
The femoral neck geometry was shifted medially by 1.5 mm .
The geometry of the insertion hole feature was modified from a dimple to the oblong . slot.
"12/14" Laser-etching was added to the face of the femoral stem taper .

The AcuMatch 12/14 L-Series Cemented femoral stems were modified from the predicate as follows:

The femoral head/neck taper geometry was modified from Exactech's proprietary . taper design to the "12/14 Euro-Style" threadform taper design
. The femoral neck length was decreased by 4mm
The femoral neck geometry was shifted medially by 1.5 mm .
. The geometry of the insertion hole feature was modified from a dimple to the oblong slot.
. "12/14" Laser-etching was added to the face of the femoral stem taper.
A cobra flange geometry was added .
The material specifications for the L-Series cemented stem were changed from cast . Co-28Cr-6Mo (ASTM F75) to forged Co-28Cr-6Mo (ASTM F799).

The Novation Cemented femoral stems were modified from the predicate as follows:

The femoral head/neck taper geometry was modified from Exactech's proprietary . taper design to a "12/14 Euro-Style" threadform taper design
. The trapezoidal cross-sectional area was modified to a circulo-trapezoidal geometry.
. A change to the sizing range and differential.
The insertion hole feature was changed from a spherical dimple to the oblong slot .
. A "12/14" Laser-etching was added to the face of the femoral stem taper.

Conclusion:

Testing and engineering evaluations were conducted to verify that the performance of the new Exactech AcuMatch 12/14 Cemented Femoral Stems and Novation Cemented Stems 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. 09/27/05

Section 4 Page 3 of 3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three lines representing the head, body, and legs.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 7 2005

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

Re: K052787

Trade/Device Names: AcuMatch 12/14 Cemented Femoral Stems; Novation 12/14 Cemented Femoral Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Codes: LZO, JDI Dated: November 22, 2005 Received: December 8, 2005

Dear Ms. Elias:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector 910(t) premised is substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encreative to regars) the Medical Device Amendments, or to commerce prior to May 26, 1776, the enatinen with the provisions of the Federal Food, Drug, devices may been reculisomed in acces approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applicat and Cosmetic Act (Act) that to not requests appt o the general controls provisions of the Act. The You may, therefore, manel me devices, seejeer to the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (sec above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA m may be subject to such additional controller Entroller - British - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 800 to 898. In additio be found in the Ood of I cases on cerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualited of a bassaint in ther requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a delerimiation that Jour as roos by other Federal agencies. You must and listing and listing or any rederal statutes and regulations administrations of the registration and listing (21 left comply with an the Act stequirements, mercaing, and 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 (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

This letter will allow you to begin marketing your device as described in your Section 510(k)
1999) 1992 – 1992 – 1992 – 19 – 1 – 1 – 1 – 1 – 1 – 1 (x) I his letter will anow you to begin manxemily of substantial equivalence of your device to a legally premarket notification. The PDA mailing of substanted by 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
rs the results of the county of 1100 - All and assesses the regulation enti If you desire specific advice for your do not of the other note the regulation entitled, contact the Office of Complaned at (210) 210-01-21 (21CFR Part 807.97). You may obtain "Misbranding by relevence to premanon noutheations.
other general information on your responsibilities under the Act from the 6800 638, 00 other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistanto at on on corn/industry/support/index.html.

Sincerely yours,

Signature

a 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 12/14 Cemented Femoral Stems Novation 12/14 Cemented Femoral Stems

Indications for Use

510(k) Number:

K052787

INDICATIONS

All Exactech Hip Systems are indicated for use in skeletally mature individuals An Exactoon rip Dysterery for hip replacement due to osteoarthritis, rheumatoid andergoing primary as post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also the surgeon as the presentation spondylitis, congenital hip dysplasia, revision of potentially marcated structions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

Cemented femoral stems and cemented acetabular cups are intended for . cemented fixation only.
Press-fit femoral stems and acetabular cups 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.
Femoral heads and endoprostheses are intended for use in cemented and . press-fit applications.

CONTRAINDICATIONS

Exactech Hip Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, without barneten over that do not allow control of the hip joint, and in patients m nouromasounar disoration marvel would cause the surgeon to expect early failure of the whose weight, ago, et unipolar and bipolar endoprostheses are also contraindicated for System: "The E Berrer anipes of degenerative changes in the acetabulum and/or pelvic fractures.

Over the Counter Use or Prescription Use X

Please do not write-below this line - use another page if needed. Concurrence of CDBA, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, Section 3 09/27/05 and Neurological Devices Page 1 of 1 510(k) Numb

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.