← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K062274 # SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321 (K062274) _Tecres S.P.A. · JWH · May 22, 2008 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K062274 ## Device Facts - **Applicant:** Tecres S.P.A. - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** May 22, 2008 - **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 temporary use (maximum 180 days) as an adjunct in total knee replacement (TKR) in 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/polymethilmethacrylate), 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 Spacer-K is a temporary, two-component unconstrained knee prosthesis consisting of femur and tibial components. Fabricated from gentamicin-loaded polymethylmethacrylate (PMMA) bone cement. Used as an adjunct during two-stage total knee replacement procedures for septic joints. Implanted by orthopedic surgeons in a clinical setting. Device provides temporary joint space maintenance and local antibiotic delivery. Patients must use mobility aids (crutches/walkers) due to material mechanical limitations. Intended for short-term use (≤180 days) until definitive prosthesis implantation. ## Technological Characteristics Two-component unconstrained knee prosthesis. Materials: Gentamicin-loaded polymethylmethacrylate (PMMA) bone cement. Form factor: Femur and tibial components. Energy source: None (passive). Sterilization: Not specified. ## 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 - Spacer-K ([K032522](/device/K032522.md)) - Biomet Stage One Disposable Cement Spacer Mold for Temporary Knee Prosthesis with Reinforcement Stem ([K050210](/device/K050210.md)) - Biomet Cobalt G HV Bone Cement ([K051532](/device/K051532.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}------------------------------------------------ Kobi74 # Spacer-K Modification MAY 22 2008 # 510 (k) Summary · 510(k) Summary Applicant/consultant: EXACTECH® INC. 2320 N.W. 66TH COURT GAINESVILLE, FLORIDA 32653 PHONE: (352) - 377 - 1140 FAX: (352) - 378 - 2617 CONTACT: Mike Simpson Manufacturer/Submitter: TECRES S.P.A. VIA ANDREA DORIA 37066 SOMMACAMPAGNA VERONA — ITALY TEMPORARY KNEE PROSTHESIS FDA owner/operator ID #: 9033624 TEMPORARY KNEE SPACER WITH GENTAMICIN PROSTHESIS, KNEE, PATELLOFEMORAOTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Date: May 21, 2008 SPACER-K 888.3560 ORTHOPAEDIC II ואח Trade/Proprietary model names: Common name: Device class: Device classification name: Regulation number: Classification panel: Classification Product Code: p 1/2 {1}------------------------------------------------ # Spacer-K Modification 510(k) Summary Continued ### DEVICE DESCRIPTION The Spacer-K is a temporary device that mimics a "total knee prosthesis". The two-component unconstrained design incorporates a femur and tibial component, it's fully formed by gentamicin/polymethyImethacrylate (PMMA) bone cement. #### INDICATIONS FOR USE Spacer-K is indicated for temporary use (maximum 180 days) as an adjunct in total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic proccss. 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/polymethilmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes ) throughout the implantation period. #### SUBSTANTIAL EQUIVALENCE: The modified Spacer-K 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-K device (K032522). Additionally, the modified Spacer-K device has a similar gentamicin release profile as that of the predicate Biomet Stage One Disposable Cement Spacer Mold for Temporary Knee Prosthesis with Reinforcement Stem (K050210) when used with predicate Biomet Cobalt G HV Bone Cement (K051532). {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. 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: K062274 Trade/Device Name: Spacer K Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH 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 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. {3}------------------------------------------------ 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. If 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 H. Millman Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health ## Enclosure {4}------------------------------------------------ ## Spacer-K Modification # Indications for Use 510(k) Number (if known): _ K062274 Device Name: Spacer-K Spacer-K is indicated for temporary use (maximum 180 days) as an adjunct in Indications for Use: total knee replacement (TKR) in skeletally mature patients undergoing a twostage 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/polymethilmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period. 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) Page ⊥ of ⊥ Nilre Ogl-fr mkn p 1/1 Division of General, Restorative, and Neurological Devices 510(k) Number K062274 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K062274](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K062274) **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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