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

The proposed Exactech BIOLOXdelta femoral heads and Biolox Option femoral heads and adapters are modifications to the existing Exactech 12/14 Alumina heads previously cleared in K032964 and K051682. The proposed femoral heads and adapters have the same general design features as the predicate device. The proposed femoral heads are manufactured from an alumina/zirconia based ceramic material known as Delta per ISO 6474-2. The Biolox Option adapters are comprised of titanium alloy per ISO 5832-3 and are intended for use with the Biolox Option femoral heads for primary and revision applications in which the taper remains intact.

The proposed femoral heads mate with the following devices:
12/14 Femoral Stems
Novation Press-Fit Femoral Stems (K042842)
Novation Splined RDD Femoral Stem (K063279)
Novation Element Press-Fit Femoral Stem (K080980)
Novation Cemented Stems (K052787)
Novation Cemented Plus (K083392)
AcuMatch Press Fit Stems (K041906, K051335)
AcuMatch Cemented Stems (K052787)
AcuMatch M-Series (K032964, K051858)
Acetabular Liners
Novation Crown Cup Standard and GXL UHMWPE Liners (K070479, K100269)
Novation Crown Cup Constrained Liners (K071676)
AcuMatch A-Series Standard and GXL UHMWPE Liners (K993082, K000242, K040613, K051556)
AcuMatch Constrained Liners (K040601)

The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:
similar indications for use
similar design features
incorporate similar materials
the same shelf life
are packaged and sterilized using the same materials and processes

AI/ML Overview

This document is about the 510(k) summary for BIOLOX® Delta and BIOLOX® Option Femoral Heads, which are medical devices. It primarily details the substantial equivalence to predicate devices based on non-clinical performance data (engineering evaluations). Therefore, the request for information related to clinical studies, human readers, ground truth establishment, and training/test set sizes for an AI/algorithm-based device is not applicable to this document.

However, I can extract the acceptance criteria and the (non-clinical) performance reported for this medical device from the provided text.

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

Test/Acceptance Criteria (per ISO 7206-10 and Ceramtec specifications / FDA Guidance)	Reported Device Performance
Burst strength (ISO-7206-10)	Engineering evaluations conducted to demonstrate substantial equivalence to predicate devices.
Fatigue strength (ISO-7206-10)	Engineering evaluations conducted to demonstrate substantial equivalence to predicate devices.
Post fatigue strength (ISO-7206-10)	Engineering evaluations conducted to demonstrate substantial equivalence to predicate devices.
Pull off force and Torque (Ceramtec specifications and FDA Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems)	Engineering evaluations conducted to demonstrate substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document describes non-clinical engineering evaluations, not clinical test sets or patient data.

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. Ground truth for clinical data is not relevant for non-clinical engineering evaluations. The "ground truth" here would be the established international standards (ISO) and regulatory guidance, which are met by the engineering tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or human adjudication was involved.

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 not an AI/algorithm-based device, and no MRMC study was performed.

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

Not applicable. This is not an AI/algorithm-based device.

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

For the engineering evaluations, the "ground truth" or reference points are established international standards (ISO 7206-10) and specific industry/regulatory guidance (Ceramtec specifications and FDA Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems).

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device and does not involve training sets.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/algorithm-based device.

Summary

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K.10301d *"1/3

BIOLOX® Delta and BIOLOX® Option Femoral Heads Special 510(k) - 510(k) Summary of Safety and Effectiveness

Company:	Exactech, Inc.2320 N.W. 66th CourtGainesville, FL 32653
	Phone: (352) 377-1140Fax: (352) 378-2617
Contact Person:	Lindy Knisely

Date: November 10, 2010

II. Proprietary Name:

Exactech BIOLOX®Delta Femoral Heads and BIOLOX® Option Femoral Heads and Adapters

Common Name: Femoral Head

Classification Name:

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-● Porous, Uncemented

Legally Marketed Devices to Which Substantial Equivalence Is Claimed: III.

510(k) Number	Trade of Proprietary Model Name	Manufacturer
K032964	Exactech 12/14 Alumina Femoral Heads	Exactech, Inc
K051682	Exactech 12/14 Alumina Femoral Heads 36mm	Exactech, Inc

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

NOV 1 0 2010

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K10301d #2/3

BIOLOX® Delta and BIOLOX® Option Femoral Heads Special 510(k) - 510(k) Summary of Safety and Effectiveness

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

V. Device Description

The proposed femoral heads mate with the following devices:

. 12/14 Femoral Stems
- 0 Novation Press-Fit Femoral Stems (K042842)
- Novation Splined RDD Femoral Stem (K063279) o
- o Novation Element Press-Fit Femoral Stem (K080980)
- Novation Cemented Stems (K052787) O
- Novation Cemented Plus (K083392) O
- AcuMatch Press Fit Stems (K041906, K051335) 0
- AcuMatch Cemented Stems (K052787) ಂ
- AcuMatch M-Series (K032964, K051858) O
Acetabular Liners .
- Novation Crown Cup Standard and GXL UHMWPE Liners (K070479, K100269) o
- Novation Crown Cup Constrained Liners (K071676) o
- AcuMatch A-Series Standard and GXL UHMWPE Liners (K993082, K000242, o K040613, K051556)
- AcuMatch Constrained Liners (K040601) o

The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:

. similar indications for use
similar design features .
. incorporate similar materials
. the same shelf life
are packaged and sterilized using the same materials and processes

Summary of Non-Clinical Performance Data VI.

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

{2}------------------------------------------------

K10301d*#3)3

BIOLOX® Delta and BIOLOX® Option Femoral Heads Special 510(k) - 510(k) Summary of Safety and Effectiveness

. Burst strength (ISO-7206-10)
. Fatigue strength (ISO-7206-10)
Post fatigue strength(ISO-7206-10) .
Pull off force and Torque (Ceramtec specifications and FDA Guidance Document . for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems)

VII. Substantial Equivalence Conclusion:

Device Comparison	Predicate	Proposed
Femoral Head	12/14 Alumina FemoralHeads	Bioloxdelta Femoral HeadsBiolox Option Femoral Headsand Adapters
Manufacturer	Exactech, Inc
Intended Use	Primary Hip Arthroplasty	Bioloxdelta: Primary HipAthroplastyBiolox Option: Primary orRevision Hip Arthroplasty
Indications for Use	Similar indications for use
Stem Compatibility	12/14 Ti-6Al-4V or CoCr Tapers with geometry to acceptceramic head
Material Composition	Conforms to recognized industry standards and requirements
Taper Bore Geometry	Similar geometry to be compatible with 12/14 trunnions
Head OD Sizes	Same OD size range
Head Offset Sizes	-3.5mm, +0mm, +3.5mm	-3.5mm, +0mm, +3.5mm,+7mm
Sterile BarrierPackaging	Same packaging materials
Sterilization	Same sterilization method

Results of engineering analyses referenced in this 510(k) submission demonstrate that the proposed Bioloxdelta femoral heads and Biolox Option femoral heads and adapters are substantially equivalent to the cleared predicate devices.

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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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird symbol.

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

Exactech, Inc. % Ms. Lindy Knisely, R.N. Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653

NOV 1 0 2010

Re: K103012 Trade/Device Name: BIOLOX® Delta Femoral Heads and BIOLOX® Option Femoral Heads and Adapters 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 Dated: October 8, 2010 Received: October 12, 2010

Dear Ms. Knisely:

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.

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Page 2 - Ms. Lindy Knisely

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 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/CDRH/CDRHOffices/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,

Mark N. Melkerson

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

Enclosure

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BIOLOX® Delta and BIOLOX® Option Femoral Heads Special 510(k) - Indications for Use

KIDSOLA 510(k) Number:

NOV 1 0 2010

Device Name: BIOLOX® Delta Femoral Heads and BIOLOX® Option Femoral Heads and Adapters

Indications:

. Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
t 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.

Prescription Use _X	and/or	Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)		(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)

Janeta de der mxm

Division of Surgical and Restorative Devices

510(k) Number K103012

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.