Spacer-G is indicated for temporary use (maximum 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). Spacer-G is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

Device Description

Spacer-G is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The one piece design mimics a hemi-hip prosthesis.

AI/ML Overview

This 510(k) summary for the Spacer-G device primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself.

Therefore, many of the requested sections about acceptance criteria, study design, and performance metrics are not explicitly detailed in this document. The core of this submission is to show that the modified Spacer-G is just as safe and effective as already approved devices by having similar design, materials, performance characteristics, and gentamicin release profile.

Here is an attempt to address your requests based on the provided text, highlighting where information is absent:

Acceptance Criteria and Study to Prove Device Meets Criteria: Spacer-G Modification

The provided 510(k) summary for the Spacer-G device demonstrates substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria directly linked to a novel performance claim for the modified device. The "acceptance criteria" can be inferred as the standard for substantial equivalence, meaning the device must perform comparably to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Goal)	Reported Device Performance
Material Composition: Same as predicate Spacer-G	"incorporates the same materials"
Design: Same as predicate Spacer-G	"has the same design"
Mechanical Characteristics: Equivalent to predicate Spacer-G	"has equivalent performance and mechanical characteristics"
Shelf Life and Packaging: Same as predicate Spacer-G	"has the same shelf and packaging"
Gentamicin Release Profile: Similar to predicate Biomet Stage One Disposable Cement Spacer Mold (K052990) when used with predicate Biomet Cobalt G HV Bone Cement (K051532)	"has a similar gentamicin release profile as that of the predicate Biomet Stage One Disposable Cement Spacer Mold... when used with predicate Biomet Cobalt G HV Bone Cement"
Intended Use: Identical to predicate device	Same Indications For Use as described.

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

This information is not provided in the 510(k) summary. Given the nature of a substantial equivalence submission relying on comparison to existing devices, it is unlikely a large "test set" in the sense of a clinical trial was used for this specific modification. The "performance" assessment appears to be based on engineering principles and potentially laboratory testing rather than human clinical outcomes data.

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

This information is not applicable/provided. The submission focuses on substantial equivalence based on technical and material characteristics, not on a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable/provided. There is no mention of a clinical test set requiring adjudication in this 510(k) summary.

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

This information is not applicable. This device is a temporary hip prosthesis, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

This information is not applicable. This device is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the performance characteristics of the legally marketed predicate devices. The modified Spacer-G is evaluated against these established benchmarks. No pathology, outcomes data, or expert consensus specific to the modified device's novel performance is referenced as a "ground truth" to meet new performance criteria.

8. The Sample Size for the Training Set

This information is not applicable. This device is not an AI algorithm requiring a training set.

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

This information is not applicable. This device is not an AI algorithm.

Summary

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Spacer-G Modification

510 (k) Summary

MAY 2 2 2008

510(k) Summary

Applicant/consultant:

Manufacturer/Submitter:

EXACTECH. INC. 2320 N.W. 66TH COURT GANESVILLE, FLORIDA 32653 PHONE: (352) - 377 - 1140 FAX: (352) - 378 - 2617 CONTACT: Mike Simpson

TECRES S.P.A. VIA ANDREA DORIA 37066 SOMMACAMPAGNA VERONA — ITALY

FDA OWNER/OPERATOR ID #: 9033624

Date:

May 21, 2008

Trade/Proprietary model names: SPACER-G TEMPORARY HIP PROSTHESIS

Common name:

TEMPORARY HEMI-HIP PROSTHESIS; TEMPORARY HIP SPACER WITH GENTAMICIN

PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Regulation number: 888.3360

Device class:

Device classification name:

Classification panel: ORTHOPAEDIC

Classification Product Code : KWL: KWY

DEVICE DESCRIPTION

Spacer-G is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The one piece design mimics a hemi-hip prosthesis.

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Spacer-G Modification 510(k) Summary Continued

INDICATIONS FOR USE:

SUBSTANTIAL EQUIVALENCE:

The modified Spacer-G device has the same design, incorporates the same materials, has equivalent performance and mechanical characteristics, and has the same shelf and packaging as the predicate Spacer-G device (K031841). Additionally, the modified Spacer-G device has a similar gentamicin release profile as that of the predicate Biomet Stage One Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement Stem (K052990) when used with predicate Biomet Cobalt G HV Bone Cement (K051532).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of several curved lines that create the shape of the bird's body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 2008

Exactech, Inc. % Mr. Xavier Sarabia Director, Regulatory Affairs 2320 N.W. 66th Court Gainesville, Florida 32653

Re: K062273

Trade/Device Name: Spacer-G Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWL, KWY Dated: February 22, 2008 Received: February 25, 2008

Dear Mr. Sarabia:

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.

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

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Page 2 - Mr. Xavier Sarabia

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

IIf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millman

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

Enclosure

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Spacer-G Modification

Indications for Use

510(k) Number (if known): _K062273

Device Name: Spacer-G

Indications for Use:

Spacer-G is indicated for temporary use (maximum 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.

The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

Spacer-G is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use No (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neilke Sle for BK
(Division Sign-Off)

Page _ of _/

Division of General, Restorative, and Neurological Devices

510(k) Number K062273

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Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.