← Product Code [LZO](/productcode/LZO) · K260173 # M-Vizion Femoral Revision System Extension (K260173) _Medacta International S.A. · LZO · Sep 17, 2026 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K260173 ## Device Facts - **Applicant:** Medacta International S.A. - **Product Code:** [LZO](/productcode/LZO.md) - **Decision Date:** Sep 17, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3353 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The hip prosthesis M-Vizion is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases: Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia. Avascular necrosis of the femoral head. Acute traumatic fracture of the femoral head or neck. Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. Mpact Constrained Liner is intended to be used as part of a Total Hip Arthroplasty, uncemented in combination with the Mpact and Mpact 3D Metal System acetabular shells. Total Hip Arthroplasty is indicated in the following cases: Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia. Avascular necrosis of the femoral head. Acute traumatic fracture of the femoral head or neck. Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty. Mpact Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. Mpact Constrained Liner should be considered only for patients with limited functional demand, as it offers a smaller range of motion than the standard total hip replacement components. The MectaCer BIOLOX® forte femoral heads and the MectaCer BIOLOX®delta femoral heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for total or partial hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patient's condition should be due to one or more of the following: Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or psoriatic arthritis, Congenital hip dysplasia, Ankylosing spondylitis, Avascular necrosis of the femoral head, Acute traumatic fracture of the femoral head or neck, Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement where sufficient bone stock is present. ## Device Story M-Vizion Femoral Revision System Extension comprises femoral stems (monoblock, distal straight, distal curved) and ceramic femoral heads. Implants replace native femoral neck/head in total or partial hip arthroplasty. Used in clinical settings by orthopedic surgeons. Devices provide mechanical structural support for hip joint reconstruction. Extension of existing product lines to include specific small diameters and curved geometries. Benefits include expanded sizing options to accommodate wider patient anatomy. Sterile, single-use components. ## Clinical Evidence No clinical studies were conducted. Evidence consists of bench testing, including fatigue testing per ISO 7206-4 and ISO 7206-6, and range of motion (ROM) evaluation per ISO 21535. Design validation was performed for distal stems and monoblock components. Pyrogenicity testing was conducted per USP <85>, <161>, and <151>. ## Technological Characteristics Modular hip prosthesis components including femoral stems and ceramic heads. Materials and design are consistent with predicate systems. Fixation is cementless. Testing performed per ISO 7206-4/6 (fatigue) and ISO 21535 (ROM). Sterilized, single-use, standalone implants. ## Regulatory Identification A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement. ## Predicate Devices - M-Vizion Monobloc ([K212327](/device/K212327.md)) - M-Vizion Femoral Revision System Extension ([K191816](/device/K191816.md)) - M-Vizion Femoral Revision System ([K170690](/device/K170690.md)) - MectaCer Biolox Delta Heads ([K112115](/device/K112115.md)) - REDAPT™ Revision Femoral System ([K151902](/device/K151902.md)) - Reclaim Revision Hip System ([K102080](/device/K102080.md)) - Pro-femur R ([K003016](/device/K003016.md)) - Mpact Constrained Liner ([K241461](/device/K241461.md)) - LINK MP Monoblock Hip Prosthesis ([K183141](/device/K183141.md)) - RECLAIM Monobloc Revision Femoral Stem ([K251292](/device/K251292.md)) - M-Vizion Femoral Revision System Extension ([K201471](/device/K201471.md)) ## Reference Devices - Medacta Total Hip Prosthesis System - Line Extension ([K080885](/device/K080885.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} FDA U.S. FOOD & DRUG ADMINISTRATION September 17, 2026 Medacta International S.A. % Christopher Lussier Senior Director, Quality and Regulatory Medacta USA 6386 Global Dr., Suite 101 Memphis, Tennessee 38141 Re: K260173 Trade/Device Name: M-Vizion Femoral Revision System Extension Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, KWY, KWZ Dated: August 17, 2026 Received: August 17, 2026 Dear Christopher Lussier: 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} K260173 - Christopher Lussier 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 {2} K260173 - Christopher Lussier Page 3 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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, # RYAN TROMBETTA -S For: Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} K260173 Page 1 of 2 # 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. K260173 Please provide the device trade name(s). M-Vizion Femoral Revision System Extension Please provide your Indications for Use below. ## M-Vizion The hip prosthesis M-Vizion is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia. - Avascular necrosis of the femoral head. - Acute traumatic fracture of the femoral head or neck. - Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. ## Mpact Constrained Liner Mpact Constrained Liner is intended to be used as part of a Total Hip Arthroplasty, uncemented in combination with the Mpact and Mpact 3D Metal System acetabular shells. Total Hip Arthroplasty is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia - Avascular necrosis of the femoral head - Acute traumatic fracture of the femoral head or neck - Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty. Mpact Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. Mpact Constrained Liner should be considered only for patients with limited functional demand, as it offers a smaller range of motion than the standard total hip replacement components. ## MectaCer Biolox® Delta Head The MectaCer BIOLOX® forte femoral heads and the MectaCer BIOLOX®delta femoral heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for total or partial hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patient's condition should be due to one or more of the following: - Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or psoriatic arthritis, - Congenital hip dysplasia, - Ankylosing spondylitis, - Avascular necrosis of the femoral head, - Acute traumatic fracture of the femoral head or neck, - Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement where sufficient bone stock is present. {4} K260173 Page 2 of 2 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) ? {5} K260173 Page 1 of 4 M-Vizion Femoral Revision System Extension Traditional 510(k) Medacta International SA # 510(k) Summary ### I. Submitter Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66 Contact Person: Stefano Baj, Regulatory Legal & Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director, Quality and Regulatory, Medacta USA Date Prepared: September 16, 2026 ### II. Device | Device Proprietary Name: | M-Vizion Femoral Revision System Extension | | --- | --- | | Common or Usual Name: | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented | | Classification Name: | Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented or Non-Porous Uncemented Prosthesis | | Primary Product Code | LZO | | Secondary Product Code | KWY, KWZ | | Regulation Number: | 21 CFR 888.3353, 21 CFR 888.3390, 21 CFR 888.3310 | | Device Classification | II | ### III. Predicate Device Substantial equivalence is claimed to the following predicate devices. Primary Predicate device: - M-Vizion Monobloc, K212327, Medacta International SA Additional Predicate devices: - M-Vizion Femoral Revision System Extension, K191816, Medacta International SA - M-Vizion Femoral Revision System, K170690, Medacta International SA - MectaCer Biolox Delta Heads, K112115, Medacta International SA - REDAPT™ Revision Femoral System, K151902, SMITH & NEPHEW, INC. - Reclaim Revision Hip System, K102080, DEPUY - Pro-femur R, K003016, Wright Medical Technology, Inc - Mpact Constrained Liner, K241461, Medacta International SA {6} K260173 Page 2 of 4 M-Vizion Femoral Revision System Extension Traditional 510(k) Medacta International SA - LINK MP Monoblock Hip Prosthesis, K183141, Waldemar Link GmbH & Co. KG - RECLAIM Monobloc Revision Femoral Stem, K251292, Depuy Ireland UC - M-Vizion Femoral Revision System Extension, K201471, Medacta International SA Reference Devices: - Medacta Total Hip Prosthesis System - Line Extension, K080885, Medacta International SA ### IV. Device Description The M-Vizion Femoral Revision System Extension is a range extension to the M-Vizion Monoblock (K212327) and M-Vizion Femoral Revision System (K191816 and K170690), as well as to the MectaCer Biolox® Delta Heads (K112115). Specifically, the devices subject of this submission are: - M-Vizion Monoblock Stem small sizes (Ø10-Ø11); - M-Vizion Distal Stem straight small sizes (Ø10-Ø11); - M-Vizion Distal Stem curved; - MectaCer Biolox® Delta Head size 22.2 M. The subject implants are intended to be used for total or partial hip arthroplasty, in primary or revision surgeries to replace the native femoral neck and femoral head; and they are provided individually packed, sterile and single-use. ### V. Indications for Use #### M-Vizion The hip prosthesis M-Vizion is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia. - Avascular necrosis of the femoral head. - Acute traumatic fracture of the femoral head or neck. - Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. #### Mpact Constrained Liner Mpact Constrained Liner is intended to be used as part of a Total Hip Arthroplasty, uncemented in combination with the Mpact and Mpact 3D Metal System acetabular shells. Total Hip Arthroplasty is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia - Avascular necrosis of the femoral head - Acute traumatic fracture of the femoral head or neck - Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty. {7} K260173 Page 3 of 4 M-Vizion Femoral Revision System Extension Traditional 510(k) Medacta International SA Mpact Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and or whom all other options to constrained acetabular components have been considered. Mpact Constrained Liner should be considered only for patients with limited functional demand, as it offers a smaller range of motion than the standard total hip replacement components. ### MectaCer Biolox® Delta Head The MectaCer BIOLOX® forte femoral heads and the MectaCer BIOLOX®delta femoral heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for total or partial hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patient's condition should be due to one or more of the following: - Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or psoriatic arthritis, - Congenital hip dysplasia, - Ankylosing spondylitis, - Avascular necrosis of the femoral head, - Acute traumatic fracture of the femoral head or neck, - Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement where sufficient bone stock is present. ### VI. Comparison of Technological Characteristics The subject and relative predicate devices (K212327, K151902, K102080, K003016, K191816 and K170690 for M-Vizion and K112115 for MectaCer Biolox® Delta Head) are substantially equivalent with respect to the following characteristics: - Indications for use; - Design; - Fixation; - Materials; - Biocompatibility; - Device usage; - Packaging; - Shelf-life; and - Sterility. The subject devices differ from the predicate devices (K212327, K151902, K102080, K003016, K191816 and K170690 for M-Vizion and K112115 for MectaCer Biolox® Delta Head) with respect to: - Range of product ### Discussion The subject M-Vizion Femoral Revision Extension size ranges have been designed to cover a wider population, but have no impact on safety and effectiveness, as demonstrated by design validation analysis and fatigue testing. {8} K260173 Page 4 of 4 M-Vizion Femoral Revision System Extension Traditional 510(k) Medacta International SA The comparison of technological characteristics and performance data provided within the submission supports the substantial equivalence of the subject devices with respect to the predicate devices. ### VII. Performance Data Based on the risk analysis, testing activities were conducted to written protocols. The following tests are provided in support of the substantial equivalence determination: Non-Clinical Studies ○ DESIGN VALIDATION - M-Vizion Distal Stem Validations - M-Vizion Monoblock Validation ○ PERFORMANCE TESTING - M-Vizion Femoral Revision System Fatigue Test according to ISO 7206-4 and ISO 7206-6 - MectaCer Biolox Delta Head Rationale - Range of Motion (ROM) Evaluation according to ISO 21535 ○ PYROGENICITY - Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85> and USP <161>) - Pyrogen test according to USP chapter <151> for pyrogenicity determination - The subject devices are not labeled as non-pyrogenic or pyrogen free. Clinical Studies: - No clinical studies were conducted. ### VIII. Conclusion The information provided above supports that the subject devices are substantially equivalent to the predicate devices. --- **Source:** [https://fda.innolitics.com/device/K260173](https://fda.innolitics.com/device/K260173) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com