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.
. Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Device Description

The proposed Novation Crown Cup Acetabular Liners and associated Liner Trials are a modification to the Novation Crown Cup Acetabular Liners and associated Liner Trials cleared through premarket notification #K070479.

The proposed 12/14 Cobalt Chromium, Bioloxdelta and Biolox Option Femoral Heads and associated Head Trials are a modification to the 12/14 Cobalt Chromium, Bioloxdelta and Biolox Option Femoral Heads and associated Head Trials cleared through premarket notifications #K041906 and #K103012.

The predicate and proposed devices have the same intended use and basic fundamental scientific technology.

The modified devices share the following similarities with the predicate devices:

. Indications for use
. Design features
Material ●
Shelf life
. Packaging and sterilization materials and processes

This submission proposes the following design change:

The proposed acetabular liners have a minimum polyethylene thickness of 4mm . for compatibility with 32mm, 36mm and 40mm femoral heads.
The proposed femoral heads have an outer diameter of 40mm. .

AI/ML Overview

The provided document describes a Special 510(k) submission for modifications to Exactech femoral heads and Novation Crown Cup acetabular liners. This is a medical device submission, not an AI/ML software submission, therefore many of the requested categories are not applicable.

Here's an analysis of the provided text in the context of the requested information:

Acceptance Criteria and Device Performance

The submission demonstrates substantial equivalence to predicate devices through various engineering analyses. The acceptance criteria essentially revolve around demonstrating performance that is "equivalent or better" than the predicate devices, or demonstrating that the proposed devices are "substantially equivalent" to them according to specific testing standards.

Table of Acceptance Criteria and Reported Device Performance

Test/Analysis	Acceptance Criteria (Demonstrated)	Reported Device Performance
Wear testing (ASTM F1714)	Equivalent or better wear results than predicate devices.	Results demonstrated equivalent or better wear than predicate devices.
Lever-out testing (Tradonsky, et al. 1993)	Substantially equivalent to predicate acetabular liner devices.	Results demonstrated substantial equivalence to predicate devices.
Axial push-out (ASTM F1820)	Substantially equivalent to predicate acetabular liner devices.	Results demonstrated substantial equivalence to predicate devices.
Torque testing	Substantially equivalent to predicate acetabular liner devices.	Results demonstrated substantial equivalence to predicate devices.
Impingement fatigue testing	Substantially equivalent to predicate acetabular liner devices.	Results demonstrated substantial equivalence to predicate devices.
Burst Testing (ISO 7206-10)	Engineering justification supported applicability of predicate device testing to proposed devices.	Covered by engineering justification, assumed equivalent performance.
Fatigue (ISO 7206-10)	Engineering justification supported applicability of predicate device testing to proposed devices.	Covered by engineering justification, assumed equivalent performance.
Post Fatigue (ISO 7206-10)	Engineering justification supported applicability of predicate device testing to proposed devices.	Covered by engineering justification, assumed equivalent performance.
Pull-Off (Ceramtec specifications, FDA Guidance, ASTM F2009)	Engineering justification supported applicability of predicate device testing to proposed devices.	Covered by engineering justification, assumed equivalent performance.
Torque (Ceramtec specifications, FDA Guidance)	Engineering justification supported applicability of predicate device testing to proposed devices.	Covered by engineering justification, assumed equivalent performance.
Range of Motion (ISO 21535)	Engineering justification supported applicability of predicate device testing to proposed devices.	Covered by engineering justification, assumed equivalent performance.

1. A table of acceptance criteria and the reported device performance:
See table above.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify exact sample sizes for each test in terms of the number of individual devices tested beyond mentioning the standards (e.g., ASTM F1714, ISO 7206-10). It refers to "engineering analyses" and "wear testing," which implies that appropriate sample sizes were used as per clinical and regulatory standards for device testing. There is no information regarding data provenance (country of origin) or whether it was retrospective or prospective, as these are typically not relevant for bench testing of medical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is a medical device submission based on physical and mechanical testing, not an AI/ML algorithm requiring expert ground truth for interpretation. The "ground truth" here is the physical performance measured against established engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. See point 3.

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 is a medical device submission, not an AI/ML algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device submission, not an AI/ML algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For this medical device, the "ground truth" or reference for performance is established by international and industry-recognized engineering standards (e.g., ASTM F1714, ISO 7206-10, ASTM F1820, Ceramtec specifications, FDA Guidance) and comparative performance against previously cleared predicate devices. The goal is to demonstrate that the modified device performs to these established physical and mechanical criteria.

8. The sample size for the training set:
Not applicable. This is a medical device submission based on physical and mechanical testing, not an AI/ML algorithm that is "trained."

9. How the ground truth for the training set was established:
Not applicable. See point 8.

Summary

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Exactech® Femoral Heads and Novation® Crown Cup® Acetabular Liners Special 510(k) - 510(k) Summary of Safety and Effectiveness

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

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

FDA Establishment Number 1038671

Contact: Nicole Kassner QA/RA Compliance, Project Manager

Date: January 11, 2013

Trade of Proprietary or Model Name(s):

Exactech® Novation® Crown Cup® GXL UHMWPE Liner Exactech 12/14 CoCr Femoral Head Exactech 12/14 Bioloxdelta® Femoral Head Exactech 12/14 Biolox Option Femoral Head Exactech Novation Crown Cup 40mm Liner Trials Exactech 12/14 40mm Head Trials

Common Name:

Total Hip Arthroplasty Prosthesis - Acetabular Liners and Femoral Heads

Classification Name:

Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented (CFR 888.3353, Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, Class II, Product Code LZO)

Prosthesis, hip, semi-constrained, metal/polymer, cemented (CFR 888.3350. Hip joint metal/polymer semi-constrained cemented, Class II, Product Code JDI)

Prosthesis, hip, semi-constrained, metal/polymer, uncemented (CFR 888.3360, Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis, Class II, Product Code LWJ)

Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calciumphosphate (CFR 888.3353, Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, Class II, Product Code MEH)

Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (CFR 888.3358, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Class II, Product Code LPH)

JAN 1 6 2013

ાજિ

K121392

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Exactech® Femoral Heads and Novation® Crown Cup® Acetabular Liners Special 510(k) - 510(k) Summary of Safety and Effectiveness

Information on devices to which substantial equivalence is claimed:

510(k) Number	Trade of Proprietary Model Name	Manufacturer
K070479	Exactech Novation® Crown Cup® Liners	Exactech, Inc.
K041906	Exactech 12/14 CoCr Femoral Heads	Exactech, Inc.
K103012	Exactech Bioloxdelta® and Biolox OptionFemoral Heads and Adapters	Exactech, Inc.

Indications for Use:

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.
. Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Device Description:

The predicate and proposed devices have the same intended use and basic fundamental scientific technology.

The modified devices share the following similarities with the predicate devices:

. Indications for use
. Design features
Material ●
Shelf life

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Exactech Femoral Heads and Novation® Crown Cup® Acetabular Liners Special 510(k) - 510(k) Summary of Safety and Effectiveness

<121392

3/3

. Packaging and sterilization materials and processes
This submission proposes the following design change:
The proposed acetabular liners have a minimum polyethylene thickness of 4mm . for compatibility with 32mm, 36mm and 40mm femoral heads.
The proposed femoral heads have an outer diameter of 40mm. .

Substantial Equivalence Conclusion:

The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed devices to the predicate devices:

Wear testing per ASTM F1714 to determine that the proposed devices have ● equivalent or better wear results than the predicate devices.
. Lever-out testing per Tradonsky, et al. 1993, Axial push-out per ASTM F1820, Torque testing was conducted to determine that the proposed acetabular liner devices are substantially equivalent to the predicate devices.
. Impingement fatigue testing was conducted to determine that the proposed acetabular liner devices are substantially equivalent to the predicate devices.
. Engineering justification to support the applicability of the predicate device testing to the proposed devices:
- Burst Testing per ISO 7206-10
- 트 Fatigue per ISO 7206-10
- 트 Post Fatigue per ISO 7206-10
- 트 Pull-Off per Ceramtec specifications, FDA Guidance and ASTM F2009
- Torque per Ceramtec specifications, FDA Guidance 이
- D Range of Motion per ISO 21535

The results of engineering analyses demonstrate the proposed devices are substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & 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 a stylized caduceus or a representation of the human form.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 16, 2013

Exactech, Incorporated % Ms. Nicole Kassner Quality and Regulatory Compliance Project Manager 2320 Northwest 66th Court Gainesville, Florida 32653

Re: K121392

Trade/Device Name: Exactech® Femoral Heads and Novation® Crown Cup® Acetabular Liners

Regulation Number: 21 CFR 888.3353

Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Regulatory Class: Class II Product Code: LZO, JDI, LWJ, MEH, LPH Dated: December 21. 2012 Received: December 26, 2012

Dear Ms. Kassner:

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 commerce prior 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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

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Page 2 - Ms. Nicole Kassner

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin Dieith

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exactech® Femoral Heads and Novation® Crown Cup® Acetabular Liners Special 510(k) - Indications for Use

510(k) Number: _

Device Name: Exactech® Femoral Heads and Novation® Crown Cup® Acetabular Liners

INDICATIONS

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 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. .
Femoral heads and endoprostheses are intended for use in cemented and � press-fit applications.

Prescription Use_ X (Part 21 CFR 801 Subpart D) and/or

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Krishna Asundi, PhD Division of Orthopedic Devices

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.