The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement and whose orthopedic surgeon desires a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The Exactech Novation InteGrip Acetabular Augment is affixed to the mating acetabular shell using PMMA bone cement. Therefore, acetabular shells with HA coating must not be used with InteGrip Acetabular Augments. The assembled construct is intended for press-fit fixation.

Device Description

The proposed Exactech Novation InteGrip Acetabular Augments are a modification of the Exactech InteGrip Acetabular Augments cleared through premarket notification #K101761.

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

The modified devices share the following similarities with predicate devices:

. Indications for Use
Design Features (e.g. screw holes, height configurations)
Material (titanium alloy) .
. Shelf Life (5 years)
Packaging and sterilization materials and processes (gamma radiation sterilization to a sterility assurance level of 10°)

The proposed devices include the following design change:

Expand the current scope of augments to include sizes that are compatible with . the Novation Crown Cup acetabular shell sizes 60-68mm (both plasma spray and InteGrip).

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Exactech® Novation® InteGrip™ Acetabular Augments). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, many of the requested elements about acceptance criteria, study design, and ground truth are not applicable or documented in this type of regulatory submission. The summary explicitly states that equivalence was demonstrated through "engineering analyses."

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission is a 510(k) for substantial equivalence, which does not typically include a table of acceptance criteria and reported device performance in the way a clinical trial or performance study would. The equivalence is based on design features, intended use, materials, manufacturing processes, and engineering analyses comparing the new device to a predicate.

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

Not applicable. This submission relies on engineering analyses rather than a "test set" of clinical data.

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

Not applicable. No ground truth was established by experts for a test set in this context. The determination of substantial equivalence was made by the FDA based on the submitted engineering analysis and comparison to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication was used.

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 a physical acetabular augment, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. There was no "ground truth" in the sense of clinical outcomes, pathology, or expert consensus used for performance evaluation. The basis for approval was substantial equivalence to a legally marketed predicate device, demonstrated through engineering analyses.

8. The Sample Size for the Training Set

Not applicable. No training set was used for an algorithm; this is a physical medical device.

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

Not applicable. No training set was used.

Summary of Device Performance and Substantial Equivalence (as reported in the document):

The Exactech® Novation® InteGrip™ Acetabular Augments (K113609) are a modification of the Exactech InteGrip Acetabular Augments (K101761).

Acceptance Criteria/Basis for Substantial Equivalence:

The primary "acceptance criteria" for this 510(k) submission were demonstrating substantial equivalence to the predicate device (Exactech InteGrip Acetabular Augments, K101761). This was achieved by showing:

Identical Indications for Use: Both devices are indicated for use in skeletally mature individuals undergoing primary or revision hip replacement surgery for segmental acetabular deficiencies, as an alternative to structural allograft.
Identical Basic Fundamental Scientific Technology: Both devices utilize the same core technology.
Similar Design Features: Including screw holes and height configurations.
Identical Material: Titanium alloy.
Identical Shelf Life: 5 years.
Identical Packaging and Sterilization: Gamma radiation sterilization to a sterility assurance level of 10⁻⁶.
Engineering Evaluation: An evaluation was conducted to confirm that the geometric features of the proposed devices (specifically, new sizes compatible with Novation Crown Cup acetabular shells 60-68mm) correspond to the compatible acetabular shells and are dimensionally and functionally similar to the predicate devices.

Study/Evidence that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets the substantial equivalence criteria is an engineering analysis. The document explicitly states:

"The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed device to the predicate Exactech Novation InteGrip Acetabular Augments:
- An engineering evaluation to determine that the geometric features of the proposed devices correspond to the compatible acetabular shells and are dimensionally and functionally similar to the predicate devices."

The conclusion drawn from this analysis is: "In addition to the design similarities, the results of engineering analyses demonstrate the proposed device is substantially equivalent to the predicate device."

In essence, for this 510(k), the "acceptance criteria" were the conditions for demonstrating substantial equivalence, and the "study" was the engineering evaluation that confirmed these conditions were met for the modified device.

Summary

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K113609

Page 1/2

Exactech® Novation® InteGrip™ Acetabular Augments Special 510(k) - 510(k) Summary of Safety and Effectiveness

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

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

FDA Establishment Number 1038671

Vladislava Zaitseva Contact: Regulatory Affairs Specialist

Date: January 4, 2012

Trade or Proprietary or Model Name(s): Exactech® Novation® InteGrip™ Acetabular Augments

Common Name: Acetabular Augment

Classification Name:

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (21 CFR 888.3358, Device Class: II, Product Code: LPH)

Information on devices to which substantial equivalence is claimed: 510/k) Number Trade or Proprietary or Model Name

510(K) Number	Trade or Proprietary or Model Name	Manufacturer
K101761	Exactech Novation InteGrip Acetabular Augments	Exactech, Inc

Indications for Use:

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K113609 Page 2/2

Exactech® Novation® InteGrip™ Acetabular Augments Special 510(k) - 510(k) Summary of Safety and Effectiveness

Device Description:

The proposed Exactech Novation InteGrip Acetabular Augments are a modification of the Exactech InteGrip Acetabular Augments cleared through premarket notification #K101761.

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

The modified devices share the following similarities with predicate devices:

. Indications for Use
Design Features (e.g. screw holes, height configurations) �
Material (titanium alloy) .
. Shelf Life (5 years)
Packaging and sterilization materials and processes (gamma radiation sterilization to a sterility assurance level of 10°)

The proposed devices include the following design change:

Expand the current scope of augments to include sizes that are compatible with . the Novation Crown Cup acetabular shell sizes 60-68mm (both plasma spray and InteGrip).

Substantial Equivalence Conclusion:

The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed device to the predicate Exactech Novation InteGrip Acetabular Augments:

An engineering evaluation to determine that the geometric features of the . proposed devices correspond to the compatible acetabular shells and are dimensionally and functionally similar to the predicate devices.
In addition to the design similarities, the results of engineering analyses demonstrate the proposed device is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

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

JAN - 4 2012

Exactech® Inc. % Ms. Vladislava Zaitseva 2320 N.W. 66th Court Gainesville, FL 32653

Re: K113609

Trade/Device Name: Exactech® Novation® InteGrip™ Acetabular Augments Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: December 5th, 2011 Received: December 6ta, 2011

Dear Ms. Zaitseva:

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. Vladislava Zaitseva

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,

Einol Keith

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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Exactech® InteGrip™ Acetabular Augments Special 510(k) - Indications for Use

510(k) Number:

K113609

Device Name: Exactech® InteGrip™ Acetabular Augments

INDICATIONS

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)

BBRS Lr

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113609

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.