← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K032522 # TECRES SPACER-K TEMPORARY KNEE PROSTHESIS (K032522) _Exactech, Inc. · JWH · May 28, 2004 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K032522 ## Device Facts - **Applicant:** Exactech, Inc. - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** May 28, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use 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 Story Temporary total knee prosthesis; two-component unconstrained design; femoral and tibial components. Composed of gentamicin-loaded polymethylmethacrylate (PMMA) bone cement. Used in two-stage arthroplasty procedures for septic knee replacement. Implanted by orthopedic surgeons in clinical/hospital settings. Provides temporary joint function and local antibiotic delivery for up to 180 days. Requires patient use of mobility aids (crutches/walkers) due to material mechanical limitations. Benefits include infection management and maintenance of joint space during revision process. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Two-component unconstrained knee prosthesis; material: gentamicin-loaded polymethylmethacrylate (PMMA) bone cement; sterile (SAL 10^-6); temporary implantation (max 180 days). ## Regulatory 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). ## Predicate Devices - Natural Knee ([K936159](/device/K936159.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 Court
Gainesville, 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.A
FDA Owner/Operator ID# 9033624 | Date: May 19, 2004 rev. 05 19 04 .............................................................................................................................................................................. Section 4 Page 1 of 3 {1}------------------------------------------------ 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-K
Temporary 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: 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 rev. 05 19 04 {2}------------------------------------------------ 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 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. ### 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 {3}------------------------------------------------ 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ ### Indications for Use #### 510(k) Number: #K032522 #### Spacer-K Temporary Knee Prosthesis Device Name: #### INDICATIONS FOR USE 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. #### 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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K032522](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K032522) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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