GSPE Spacer

{0} **U.S. FOOD & DRUG** ADMINISTRATION September 11, 2026 The General Hospital Corporation, d/b/a Massachusetts % Hollace Rhodes Vice President, Orthopedic Regulatory Affairs MCRA, LLC 803 7th St., NW Washington, District of Columbia 20001 Re: K260063 Trade/Device Name: GSPE Spacer 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, MBB Dated: August 12, 2026 Received: August 12, 2026 Dear Hollace Rhodes: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K260063 - Hollace Rhodes Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K260063 - Hollace Rhodes Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Robert M. Stefani -S Digitally signed by Robert M. Stefani -S Date: 2026.09.11 12:41:14 -04'00' For: Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260063 | ? | | Please provide the device trade name(s). | | ? | | GSPE Spacer | | | | Please provide your Indications for Use below. | | ? | | The GSPE Spacer includes femoral and tibial components, and is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage revision procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting microorganism(s).The device is applied on the femoral condyles and on the tibial plateau following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).The GSPE Spacer 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.) Because of the inherent mechanical limitations of the device materials, the device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period. | | | | Please select the types of uses (select one or both, as applicable). | Prescription Use (21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} K260063 Page 1 # 510(k) Summary Device Trade Name: GSPE Spacer Manufacturer: The General Hospital Corporation d/b/a Massachusetts General Hospital MGB Innovation STE 999 399 Revolution Drive Somerville, MA 02145 Prepared by: MCRA, LLC 803 7th Street, NW, 4th Floor Washington, DC 20001 Office: 202.552.5800 Date Prepared: September 11, 2026 Classifications: 21 CFR 888.3560, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Product Code: JWH, MBB Class: II Primary Predicates: The Knee Spacer (REMEDY Knee Spacer), K112470 Rx Knee System, K240683 Reference Devices: NexGen Knee (K933785), StageOne™ Knee Cement Spacer Molds (K213287) # Indications For Use: The GSPE Spacer includes femoral and tibial components, and is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage revision procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting microorganism(s). {5} K260063 Page 2 The device is applied on the femoral condyles and on the tibial plateau following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The GSPE Spacer 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.) Because of the inherent mechanical limitations of the device materials, the device 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 GSPE Spacer is a single-use knee spacer which consists of a femoral component and tibial component and is indicated for temporary use as an adjunct to total knee replacement in patients undergoing a two-stage revision procedure due to a periprosthetic joint infection. The GSPE Spacer includes a femoral component available in two materials (i.e., UHMWPE blended with gentamicin sulfate or Cobalt Chrome alloy) and a tibial component manufactured from UHMWPE blended with gentamicin sulfate. The gentamicin sulfate in the GSPE material is intended to protect the device from colonization. The GSPE Spacer is intended to provide patients with a temporary implant that allows for a natural range of motion and partial weight-bearing while implanted to preserve the soft tissue to prevent further complications, such as muscular contracture, to facilitate the subsequent joint replacement procedure. # **Predicate and Reference Devices:** Mass General submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the GSPE Spacer is substantially equivalent in indications, design principles, and performance to the following devices: # ***All-GSPE Spacer*** Primary Predicate: The Knee Spacer (REMEDY Knee Spacer) K112470 References Devices: NexGen Knee (K933785), StageOne™ Knee Cement Spacer Molds (K213287) # ***CoCr-GSPE Spacer*** Primary Predicate: Rx Knee System K240683 References Devices: NexGen Knee (K933785), StageOne™ Knee Cement Spacer Molds (K213287) # **Substantial Equivalence:** The GSPE Spacer, primary predicate, and reference devices are all intended to be used in the first stage of a two-stage revision procedures in patients with periprosthetic joint infection subsequent to total knee arthroplasty. All share the same primary function as a temporary knee implant to {6} K260063 Page 3 allow for a natural range of motion and partial weight-bearing. The All-GSPE Spacer and all other knee spacers employ gentamicin as the antibiotic which protects the device from colonization. The antibiotic in the GSPE Spacer elutes from polyethylene while the antibiotic in the Knee Spacer (K112470) and spacers made with StageOne molds (K213287) elutes from PMMA. The subject device CoCr-GSPE Spacer is similar to the predicate device, the Rx Knee System (K240683), in that both offer a CoCr femoral component and a tibial component made of polyethylene. The subject device was demonstrated to be substantially equivalent to the predicate and reference devices with respect to indications for use, intended use, design, principles of operation, and materials. The subject device does not raise any new safety or effectiveness concerns. # Performance Testing: The GSPE Spacer underwent extensive testing and analyses including: - wear - elution - antibacterial activity - gentamicin stability - range of motion - polyethylene characterization - biocompatibility assessments - sterilization validation - pyrogenicity - EO and ECH residuals The results of the performance testing support the substantial equivalence of the GSPE Spacer. # Conclusion: Based on similarities in intended use, indications for use, design, principles of operation, materials, and performance characteristics, the GSPE Spacer is substantially equivalent to the identified predicate and reference devices.