← Product Code [KWY](/productcode/KWY) · K253357 # b-ONE® Bipolar Head (K253357) _B-One Ortho, Corp. · KWY · Apr 13, 2026 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K253357 ## Device Facts - **Applicant:** B-One Ortho, Corp. - **Product Code:** [KWY](/productcode/KWY.md) - **Decision Date:** Apr 13, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3390 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The Bipolar Head is intended to be used for hemi-hip arthroplasty with evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem and is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly. 6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty. ## Device Story Bipolar hemi-hip arthroplasty component; consists of CoCr shell, UHMWPE liner, and UHMWPE retaining ring. Provides dual-articulation: primary at femoral head/inner liner interface; secondary at outer shell/acetabulum interface. Compatible with b-One CoCr/ceramic heads (28mm) and specific femoral stems (Kosmo, Juveno). Used by orthopedic surgeons in clinical settings for hip reconstruction. Implant replaces femoral head while preserving natural acetabulum. Benefits include restoration of hip function and mobility in patients with femoral-specific pathology. Device is a line extension to existing hip system. ## Clinical Evidence Bench testing only. No clinical data provided. Testing included material characterization, range of motion (ISO 21535), impingement (ASTM F2582), pull-off/lever-off disassembly, wear testing, endotoxin testing (USP<85>), and biocompatibility (ISO 10993-1). ## Technological Characteristics Materials: CoCr (ASTM F75) shell, UHMWPE (ASTM F648) liner and retaining ring. Dual-articulation design. Sizes: 26 options (40-65mm). Compatible with 28mm femoral heads. Sterilization method not specified. No software or electronics. ## Regulatory Identification A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction. ## Predicate Devices - DePuy Self Centering Hip ([K812672](/device/K812672.md)) ## Reference Devices - Stryker UHR Bipolar ([K800207](/device/K800207.md)) - Stryker Centrax ([K855231](/device/K855231.md)) - Stryker Centrax ([K972792](/device/K972792.md)) - b-One CoCr and ceramic heads ([K173380](/device/K173380.md)) - Kosmo Femoral Stems ([K202768](/device/K202768.md)) - Kosmo Femoral Stems ([K240528](/device/K240528.md)) - Juveno Femoral Stems ([K182705](/device/K182705.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 April 13, 2026 B-One Ortho, Corp. Allison Gecik Director, US Quality & Regulatory 3 Wing Dr., Suite 259 Cedar Knolls, New Jersey 07927 Re: K253357 Trade/Device Name: b-ONE® Bipolar Head Regulation Number: 21 CFR 888.3390 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWY Dated: December 1, 2025 Received: December 1, 2025 Dear Allison Gecik: 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} K253357 - Allison Gecik 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} K253357 - Allison Gecik 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-S 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} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K253357 | | | Device Name b-ONE® Bipolar Head | | | Indications for Use (Describe) | | | The Bipolar Head is intended to be used for hemi-hip arthroplasty with evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem and is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly. 6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty. | | | 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." | | {4} K253357 Page 1 of 3 TRADITIONAL 510(K) SUMMARY As required by 21 CFR 807.92 Submitter Information: Submitter’s Name: b-ONE ORTHO, Corp. Address: 3 Wing Drive Suite 259 Cedar Knolls, NJ 07927 Telephone: 973-965-8940 Contact Person: Allison Gecik Date Prepared: April 12, 2026 Proprietary Name: b-ONE® Bipolar Head Classification Panel: Orthopedic Classification: Class II Classification Regulation/Product Codes: | Subject Devices | Product Code | Regulation Number | Regulation Name | | --- | --- | --- | --- | | b-ONE® Bipolar Head | KWY | 888.3390 | Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. | Predicate Device and Reference Device: | Predicate and Reference Device | | | | --- | --- | --- | | Predicate Device | Corresponding Predicate Regulation(s) | Corresponding Predicate Product Code(s) | | K812672, DePuy Self Centering Hip (Primary) | 888.3390 | KWY | | K800207, Stryker UHR Bipolar (Reference) | 888.3360 | KWL | | K855231; K972792, Stryker Centrax (Reference) | 888.3390 | KWY | {5} K253357 Page 2 of 3 ## Indications for Use: The Bipolar Head is intended to be used for hemi-hip arthroplasty with evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem and is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly. 6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty. ## Device Description/Technological Characteristics The Bipolar Head is a hemi-hip component consisting of a CoCr (ASTM F75) shell, UHMWPE (ASTM F648) Liner and UHMWPE (ASTM F648) Retaining ring. The single assembled bipolar head implant construct provides primary articulation at the femoral head and inner polyethylene bearing interface, and secondary articulation at the outer shell and acetabulum interface. The internal aspect of the shell is designed to lock the polyethylene liner utilizing a polyethylene ring. The outer metal surface of the bipolar implant allows for articulation with the patient's acetabulum. The Bipolar Head is compatible with the b-One CoCr and ceramic heads size 28mm (K173380). This device is offered in 26 sizes ranging from 40-65mm each with a 28mm head. ## Comparison of Technological Characteristics (compared to Predicate(s)) The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The Bipolar Head and the predicate devices share the following characteristics: - Materials of construction - Sizes within the same range - Similarity in shape - Sterilization methods ## Performance Testing - Bench The following performance data were provided in support of the substantial equivalence determination. ## Non-Clinical Studies for Bipolar Head | • Material Characterization | • Endotoxin Testing (USP<85>) | | --- | --- | | • Range of Motion Testing (ISO 21535) | • Biocompatibility Assessment (ISO 10993-1) | | • Impingement Testing (ASTM F2582) | • Pull-off and lever-off disassembly of Bipolar Head | | • Wear Testing Assessment | | {6} K253357 Page 3 of 3 # Conclusion This subject 510(k) premarket notification is being submitted as a line extension to the existing b-ONE® Hip System devices. The b-ONE Bipolar Head is being introduced to be compatible with the Kosmo Femoral Stems (cleared under K202768; K240528) as well as Juveno Femoral Stems (cleared under K182705). Where minor differences in design and technology exist between the subject and predicate devices, performance testing/evaluations and additional comparisons to reference devices were used to support substantial equivalence. --- **Source:** [https://fda.innolitics.com/device/K253357](https://fda.innolitics.com/device/K253357) **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