Resolve Modular Revision Hip Stem

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION May 1, 2025 United Orthopedic Corporation Lois Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu, 30075 Taiwan Re: K242315 Trade/Device Name: Resolve Modular Revision Hip Stem 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: MEH, LZO, KWY Dated: August 5, 2024 Received: August 5, 2024 Dear Lois Ho: 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 &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K242315 - Lois Ho 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 systems (QS) regulation (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} K242315 - Lois Ho 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,  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} K242315 Page 1 of 1 | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K242315 | | | Device Name Resolve Modular Revision Hip Stem | | | Indications for Use (Describe) 1. Non-inflammatory degenerative joint disease Including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. | | | This device is a single use implant and intended for cementless use only. | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | FORM FDA 3881 (8/23) PNC Publishing Services (301) 443-6740 {4} Traditional 510(k) Resolve Modular Revision Hip Stem UNITED ORTHOPEDIC # 510(K) SUMMARY # Traditional 510(k) [as required by 21 CFR 807.92(c)] Prepared by date: 2025-0501 ## Contact Details | Applicant Name | United Orthopedic Corporation | | --- | --- | | Applicant Address | No. 16, Luke 1st Rd. Luzhu Dist., Kaohsiung 82151 Taiwan | | Applicant Contact Telephone | +88635773351 | | Applicant Contact | Ms. Lois Ho | | Applicant Contact Email | lois.ho@unitedorthopedic.com | ## Device Name | Device Trade Name | Resolve Modular Revision Hip Stem | | --- | --- | | Common Name | Modular Femoral Stem | | Classification Name | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis | | Regulation Number | 888.3353 888.3390 | | Product Codes | MEH, LZO, KWY | ## Predicate Device Information | 510(k) Number | Predicate Trade Name | | --- | --- | | K090757 | Arcos® Modular Femoral Revision System | | K022549, K051363, K213129 | Restoration® Modular System | | K994126 | MODULAR-PLUS REVISION STEM | | K003237 | U2 Hip Stem, HA/Ti plasma spray | | K172251 | UTS Stem, Ti plasma spray | | K050262 | U2 Acetabular Component | | K110245 | UTF Stem | | K183312 | Conformity Stem | ## Device Description Summary Resolve Modular Revision Hip Stem is a modular stem optimized for femoral primary or revision surgery. It consists of three main components, (1) Resolve Proximal Component Resolve offers two types of proximal components, each available with either HA/Ti plasma spray or Ti plasma spray. Page 1 of 5 {5} Traditional 510(k) Resolve Modular Revision Hip Stem UNITED ORTHOPEDIC | Type | With or without Hole | Coating | Device Name | | --- | --- | --- | --- | | 1 | With Hole | HA/Ti plasma spray | Resolve Proximal Component | | | With Hole | Ti plasma spray | Resolve Proximal Component, Ti Plasma Spray | | 2 | No Hole | HA/Ti plasma spray | Resolve Proximal Component, No Hole | | | No Hole | Ti plasma spray | Resolve Proximal Component, Ti Plasma Spray, No Hole | (2) Resolve Distal Stem. Resolve offers four types of distal stems including Taper Stem, Clothespin Stem, Clothespin With Hole Stem, and Interlocking Stems. The Clothespin With Hole Stem and Interlocking stem provide holes for additional Distal Interlocking Screw fixation. The Taper Stem does not have a coating. The other three types of stems are each available with either HA/Ti plasma spray or Ti plasma spray. | Type | With or without Hole | Coating | Device Name | | --- | --- | --- | --- | | 1. Taper Stem | No Hole | Without Coating | Resolve Distal Stem, Taper | | 2. Clothespin Stem | No Hole | HA/Ti plasma spray | Resolve Distal Stem, Clothespin | | | No Hole | Ti plasma spray | Resolve Distal Stem, Ti Plasma Spray, Clothespin | | 3. Clothespin With Hole Stem | With Hole | HA/Ti plasma spray | Resolve Distal Stem, Clothespin With Hole | | | With Hole | Ti plasma spray | Resolve Distal Stem, Ti Plasma Spray, Clothespin With Hole | | 4. Interlocking Stem | With Hole | HA/Ti plasma spray | Resolve Distal Stem, Interlocking | | | With Hole | Ti plasma spray | Resolve Distal Stem, Ti Plasma Spray, Interlocking | (3) Resolve Distal Interlocking Screw It is used with Resolve Clothespin With Hole Stem and Interlocking stem to provide an extra distal fixation and prevent subsidence. Resolve Modular Revision Hip Stem can be used with "United" metallic femoral heads (K994078, K022520, K111546, K122504, K152439, K162957, K221675) or ceramic femoral heads (K103497, K112463, {6} Traditional 510(k) Resolve Modular Revision Hip Stem UNITED ORTHOPEDIC | | K122185). | | --- | --- | | - Resolve Proximal Component | | | Resolve offers two types of proximal component, with hole and no hole. The hole type provides a hole design on the lateral side of the proximal component. Both types are manufactured from Ti-6Al-4V alloy that complied with ASTM F136. There are two types of coating at the distal part of the proximal component. The first type is plasma spray coated with dual coatings, CP Ti powder (ASTM F1580) for the first layer, and HA powder (ASTM F1185, ISO 13779-6) for the second layer. The second type is plasma spray coated with only CP Ti powder (ASTM F1580). There are also two types of offset design, standard offset and high offset. Resolve Proximal Component are available in various diameters and proximal body heights. | | | - Resolve Distal Stem, Taper | | | Resolve Distal Stem, Taper is manufactured from Ti-6Al-4V alloy that complied with ASTM F136. The surface is grit-blasted. Resolve Distal Stem, Taper offers two stem lengths and is available in various diameters. | | | - Resolve Distal Stem, Clothespin | | | Resolve Distal Stem, Clothespin offers two types of proximal component, with hole and no hole. It is manufactured from Ti-6Al-4V alloy that complied with ASTM F136. Two types of coating identical to Resolve Proximal Component, HA/Ti dual coating and Ti single coating. All types of Resolve Distal Stem, Clothespins are available in various diameters. | | | - Resolve Distal Stem, Interlocking | | | Resolve Distal Stem, Interlocking is manufactured from Ti-6Al-4V alloy that complied with ASTM F136. Two types of coating identical to Resolve Proximal Component, HA/Ti dual coating and Ti single coating. Both types have the hole design to be used with Resolve, Distal Interlocking Screw to provide an extra distal fixation and prevent subsidence. All types of Resolve Distal Stem, Interlocking are available in various diameters. | | | - Resolve, Distal Interlocking Screw | | | Resolve, Distal Interlocking Screw is manufactured from Ti-6Al-4V alloy that complied with ASTM F136. It is used with Resolve Clothespin With Hole Stem and Interlocking stem to provide an extra distal fixation and prevent subsidence. It is available in various lengths. | | | Intended Use/Indications for Use | 1. Non-inflammatory degenerative joint disease Including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. | Page 3 of 5 {7} Traditional 510(k) Resolve Modular Revision Hip Stem UNITED ORTHOPEDIC | | 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. This device is a single use implant and intended for cementless use only. | | --- | --- | | **Indications for Use Comparison** | The indication for use of the subject device are similar to the predicate devices. | | **Technological Comparison** | The Subject device fundamental scientific principles and technological characteristics, including: material and general design, are the same as, or similar to, the primary predicate and the chosen additional predicate/reference devices. Summary of the technological characteristics: - Applied anatomical sites, operating principles, and conditions of use are identical. - No new risks associated to the Subject device compared to those of the predicate devices. - Material are similar to the primary predicate. - Geometry and size: Most of the sizes of the Subject device are bracketed in size by the predicates, except for the diameter of Resolve Distal Stem, Taper and the length of Resolve, Distal Interlocking Screw. The worst-case of Resolve Distal Stem, Taper and Resolve, Distal Interlocking Screw have been demonstrated equivalent safety and effectiveness as compared to the predicate devices. - Sterilization: identical method as predicates. The technological characteristics of the Subject device are substantially equivalent to the predicate device(s). | | **Non-Clinical and/or Clinical Tests Summary & Conclusions** | Based on the design rationale of the Subject device, the following tests were conducted to evaluate the safety and effectiveness of the subject device, and the test results indicated that this device is safe and effective. • Range of Motion (ISO 21535) • Pull-out Strength of Morse Taper (ISO 7206-10) • Neck Fatigue Test (ISO 7206-6) • Stem Fatigue Test combined with Disassembly Test (ISO 7206-4, ISO 7206-10) • Fretting Corrosion (ASTM F1875) • Torsional Testing of Resolve Proximal Screw (ASTM F543) • Mechanical Testing of Resolve Distal Interlocking Screw (ASTM F543) • Characterization of HA/Ti Plasma Spray Coating (FDA guidance "510(k) information needed for Hydroxyapatite Coated Orthopedic Implants") • Characterization of Ti Plasma Spray Coating (FDA guidance "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Post market Surveillance Requirements") | Page 4 of 5 {8} Traditional 510(k) Resolve Modular Revision Hip Stem UNITED ORTHOPEDIC | | • Usability Evaluation (BS EN 62366-1, FDA guidance "Content of Human Factors Information in Medical Device Marketing Submissions", "Applying Human Factors and Usability Engineering to Medical Devices.") • Bacteria endotoxin testing was conducted and met the endotoxin limit as specified in USP<I 61 > No clinical studies were required or provided. Based upon showing equivalence in the following aspects: intended use, patient population, site of application, conditions of use, operating principles, and the non-clinical performance data, the Subject device has been shown to be safe and effective and to perform equivalently as compared to the legally marketed predicate devices. Therefore, the Subject device is substantially equivalent to the legally marketed predicate devices. | | --- | --- | Page 5 of 5