Spacer-K is indicated for use as a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. Spacer-K is only indicated for an implantation period of 180 days or less. Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

Device Description

The Spacer-K is a temporary device that mimics a "total knee prosthesis". The twocomponent unconstrained design incorporates a femoral and a tibial component. The device is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The device is supplied sterile to an assurance level (SAL) of 10-6

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets them. Instead, it is a 510(k) premarket notification for a medical device (Tecres Spacer-K, a temporary knee prosthesis).

The document mainly focuses on:

Administrative Information: Applicant/Consultant, Manufacturer, Date, Contact Person.
Classification Information: Classification name, product code, CFR section, device class, classification panel, trade/proprietary names.
Substantial Equivalence: Comparison to a legally marketed predicate device ("Natural Knee" - K936159).
Device Description: Two-component unconstrained design (femoral and tibial), made of gentamicin/PMMA bone cement, supplied sterile.
Indications for Use: Temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process, for an implantation period of 180 days or less, with consistent use of mobility assist devices due to mechanical limitations.
Contraindications: A comprehensive list of conditions under which the device should not be used.
FDA Clearance Letter: Confirmation of substantial equivalence and permission to market.

Therefore, I cannot provide a table of acceptance criteria and device performance, nor details about a study evaluating these criteria, as this information is not present in the provided text.

The document is a regulatory submission for premarket clearance, which typically establishes substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.

Summary

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K03>522

page 17

2320 NW 66TH COURT GAINESVILLE, FL 32653

352-377-1140 FAX 352-378-2617

MAY 2 8 2004

Exactech

Tecres Spacer-K

Summary of Safety and Effectiveness Traditional 510(k)

Applicant/ Consultant:	Exactech ® Inc.2320 N.W. 66th CourtGainesville, Florida 32653
	Phone: (352) - 377 - 1140
	Fax: (352) - 378 - 2617
	Contact: Gary J. Miller, Ph.D.Exec. V.P. of R&D
Manufacturer/Submitter:	Tecres S.p.AFDA Owner/Operator ID# 9033624

Date:

May 19, 2004

rev. 05 19 04

..............................................................................................................................................................................

Section 4 Page 1 of 3

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Ko)x-22 page 2

Exactech

2320 NW 661H COURT GAINESVILLE, FL 32653

352-377-1140 FAX 352-378-2617

Tecres Spacer-K

Summary of Safety and Effectiveness Traditional 510(k)

Classifications / Proprietary Names:

Classification Name:	Knee joint, femoral and tibial components,polymeric, cemented
Product code:	JWH
C.F.R. Section:	888.3560
Device Class:	II
Classification Panel:	Orthopaedic
Trade / Proprietary Model Names:	Spacer-KTemporary Knee Prosthesis

Legally Marketed Device for Substantial Equivalence Comparison:

The Spacer-K device is substantially equivalent to the "Natural Knee". The device was cleared for marketing through premarket submission #K936159.

Model	Manufacturer	510(k) Number
Natural Knee	Centerplus(Sulzer, Intermedics)	#K936159

Device Description:

rev. 05 19 04

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K03r522 pg. 173

Image /page/2/Picture/1 description: The image shows the word "Exactech" in white letters against a black background. To the left of the word is a white dot. The font is bold and sans-serif.

2320 NW 66TH COURT GAINESVILLE, FI 32653

Tecres Spacer-K

352.377-1140 FAX 352-378-2617

Summary of Safety and Effectiveness Traditional 510(k)

INDICATIONS FOR USE

CONTRAINDICATIONS

Use of Spacer-K is contraindicated in the following situations:

ﺪ The patient's condition is such that a two-stage arthroplasty procedure is contraindicated due to decreased immune response or other relevant systemic clinical conditions.
-Bone loss precluding adequate support of the prosthesis.
Lack of adequate competence (anatomical and functional) of peripheral ligamentous ﮯ apparatus and extensor mechanism.
The procedure is unjustified due to deficiencies in the patient's muscular, nervous or » vascular systems.
ﻴ Poor bone quality (as in osteoporosis) could cause the prosthesis to migrate or to fracture host bonc.
Infection of the TKR cannot be confirmed. -
The infected TKR devices cannot be removed. .
The infecting pathogens are resistant to gentamicin. r
The patient is sensitive (allergic) to gentamicin, aminoglycosides or PMMA bone : cement.
A systemic or secondary remote infection is suspected or confirmed. .
The patient does not have a TKR and the infection is secondary to trauma, septic arthritis or other surgical procedures.
The patient does not have sufficient bone stock to allow insertion and fixation of " the prosthesis
The patient has neuromuscular disorders that do not allow control of the knee joint. •
The patient's weight, age or activity level would cause the surgeon to expect early failure of the system.

rev. 05 19 04

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the logo.

Public Health Service

MAY 2 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Simpson Senior Regulatory Representative Exactech. Inc. 2320 NW 66th Court Gainesville, Florida 32653

Re: K032522

Trade/Device Name: Spacer-K Temporary Knee Prosthesis Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis --Regulatory Class: II Product Code: JWII Dated: March 4, 2004

Dear Ms. Simpson:

Received: March 5, 2004

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 for ass range ior 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 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 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 - Ms. Lisa Simpson

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will and w you to ought mains of substantial equivalence of your device to a legally prematicated predicated. " results in a classification for your device 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 If you desire specific acripliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Millkern

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: #K032522

Spacer-K Temporary Knee Prosthesis Device Name:

INDICATIONS FOR USE

CONTRAINDICATIONS

Use of Spacer-K is contraindicated in the following situations:

The patient's condition is such that a two-stage arthroplasty procedure is contraindicated due to decreased immune response or other relevant systemic clinical conditions.
Bone loss precluding adequate support of the prosthesis. -
Lack of adequate competence (anatomical and functional) of peripheral ligamentous apparatus and extensor mechanism.
The procedure is unjustified due to deficiencies in the patient's muscular, nervous or vascular systems.
Poor bone quality (as in osteoporosis) could cause the prosthesis to migrate or to fracture host bone.
Infection of the TKR cannot be confirmed. -
The infected TKR devices cannot be removed. -
The infecting pathogens are resistant to gentamicin. ﮯ
The patient is sensitive (allergic) to gentamicin, aminoglycosides or PMMA bone cement.
A systemic or secondary remote infection is suspected or confirmed. -
The patient does not have a TKR and the infection is secondary to trauma, septic arthritis or other surgical procedures.
The patient does not have sufficient bone stock to allow insertion and fixation of the prosthesis
The patient has neuromuscular disorders that do not allow control of the knee joint.
The patient's weight, age or activity level would cause the surgeon to expect early failure of the system.

Prescription Use X or Over the Counter Use No

Mark N. Milkerson
(Division Sign-Off)
Please do not write below this line - use another page if needed.
Division of General, Restorative,rence of CDRH, Office of Device Evaluation (ODE)
and Neurological Devices

510(k) Number K032522

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.