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Sign in to claim this brandWISHBONE MEDICAL INC.
US
Last updated September 17, 2026
What WISHBONE MEDICAL INC. makes
WishBone Medical Inc. manufactures orthopaedic fixation hardware, including non-bioabsorbable titanium plates, screws, and bone washers for fracture stabilization and spinal applications. Their portfolio also includes single-use surgical tools such as drill guides, positioning instruments for prosthesis implantation, and procedure kits designed for orthopaedic surgeries. Examples include locking and cortical screws, compression plates, and modular systems like the PRIMA Femoral Locking Plate System.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identification (UDI) database. Their products are intended for use in orthopaedic procedures and are regulated under U.S. medical device laws, adhering to applicable standards for safety and performance. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does WishBone Medical Inc. manufacture?
WishBone Medical Inc. specializes in orthopaedic fixation devices, primarily made from non-bioabsorbable titanium. Their product line includes non-bioabsorbable orthopaedic fixation plates, bone screws (both cortical and locking), bone washers, and single-use surgical tools like drill guides and positioning instruments for orthopaedic prosthesis implantation. They also offer modular orthopaedic procedure kits designed for specific surgical applications, such as fracture stabilization and spinal procedures.
Where is WishBone Medical Inc. based, and how does that affect its regulatory oversight?
WishBone Medical Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to regulation under the U.S. Food and Drug Administration (FDA) medical device laws. The FDA classifies their products—such as fixation plates, screws, and single-use surgical tools—as either Class I or Class II, depending on their intended use and risk level, ensuring compliance with applicable safety and performance standards.
Which regulatory registries or databases list WishBone Medical Inc.’s devices?
WishBone Medical Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. The UDI system assigns a unique product identifier to each device, improving tracking, transparency, and regulatory compliance. This listing helps healthcare providers, regulators, and other stakeholders verify the identity and regulatory status of their products.
How are WishBone Medical Inc.’s devices classified under FDA regulations?
WishBone Medical Inc.’s devices are classified under the FDA’s Class I and Class II categories. Class I generally includes low-risk devices like some orthopaedic fixation plates and bone washers, which may be exempt from certain pre-market submissions but still require compliance with general controls. Class II devices, such as certain locking screws or modular orthopaedic kits, involve higher risks and require special controls (e.g., performance standards or post-market surveillance) to ensure safety and effectiveness.
What kinds of orthopaedic procedures are WishBone Medical Inc.’s devices intended for?
WishBone Medical Inc.’s devices are designed for orthopaedic surgeries involving fracture fixation, spinal stabilization, and joint replacement procedures. Their non-bioabsorbable titanium plates, screws, and washers are used to stabilize broken bones, while single-use tools like drill guides and positioning instruments assist in precise surgical placement. Modular systems, such as their femoral locking plate kits, are tailored for complex fractures or reconstructive surgeries requiring tailored hardware solutions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 1560 N State Road 5, Larwill, IN, 46764
- Website
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- —
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3013680140
- DUNS Number
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Catalogue (3014)
Page 1 of 61| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Smart Correction | 10-700-24006PA-0 | FDA UDI | Class II | Unknown |
| Smart Correction | 11-705-430151S | FDA UDI | Class II | Unknown |
| WishFIX | PK-EFC0212SS-08-US | FDA UDI | Class II | Active |
| Procedure Kit Straight Compression Plate 4 hole with 3.5mm Instruments Ti | PK-SCP3504-TI | FDA UDI | Class II | Active |
| EpiFIX | XK-EFC0222S | FDA UDI | Class II | Unknown |
| Smart Correction | 50-1860-203BL-WB | FDA UDI | Class II | Unknown |
| Smart Correction | 704-415151S | FDA UDI | Class II | Unknown |
| Smart Correction | 11-708-950200S | FDA UDI | Class II | Unknown |
| Smart Correction | 31-700-07006GA-0 | FDA UDI | Class II | Unknown |
| WishBone K-Wire System | 51-904-101216G-1 | FDA UDI | Class I | Active |
| WishFIX | XK-EFC0426T-08 | FDA UDI | Class II | Active |
| 2.7mm x 28mm Ti Cortical Screw | TCX27028-US | FDA UDI | Class II | Active |
| WishFIX | PK-EFC0220S-08-US | FDA UDI | Class II | Active |
| Smart Correction | 50-1018-24A-WBNS | FDA UDI | Class II | Unknown |
| Smart Correction | 31-700-08006BA-0 | FDA UDI | Class II | Unknown |
| Superior Mid-Shaft Narrow Clavicle Plate Procedure Kit 6 hole Right with 3.5mm | PK-SMC0635R-TI | FDA UDI | Class II | Unknown |
| 3.5mm x 26mm Ti Locking Screw | TLK35026-US | FDA UDI | Class II | Active |
| Smart Correction | 10-700-10506GA-0 | FDA UDI | Class II | Unknown |
| Smart Correction | 31-700-21006UA-0 | FDA UDI | Class II | Unknown |
| Smart Correction | 50-1860-154S-WBNS | FDA UDI | Class II | Unknown |
| Smart Correction | 50-1860-205BL-WBNS | FDA UDI | Class II | Unknown |
| Smart Correction | 50-1850-184BL-WB | FDA UDI | Class II | Unknown |
| Smart Correction | 50-1071-16S-WBNS | FDA UDI | Class II | Unknown |
| Sterile Spine Pedicle Screw System | 06.6638B-WB | FDA UDI | Class II | Unknown |
| Sterile Spine Pedicle Screw System | 06.6395B-WB | FDA UDI | Class II | Unknown |
| WishFIX | XK-EFC0422ST-08 | FDA UDI | Class II | Active |
| Smart Correction | 50-1860-154BL-WBNS | FDA UDI | Class II | Unknown |
| Sterile Spine Pedicle Screw System | 06.6419B-1-WB | FDA UDI | Class II | Unknown |
| Sterile Spine Pedicle Screw System | 06.6361B-1-WB | FDA UDI | Class II | Unknown |
| Smart Correction | 10-700-13506AA-0 | FDA UDI | Class II | Unknown |
| Smart Correction | 11-707-530250S | FDA UDI | Class II | Unknown |
| Smart Correction | 10-700-15006UA-0 | FDA UDI | Class II | Unknown |
| Smart Correction | 11-706-930200S | FDA UDI | Class II | Unknown |
| WishFIX | EFC0212S-08 | FDA UDI | Class II | Active |
| Smart Correction | 31-700-16538UA-0 | FDA UDI | Class II | Unknown |
| Smart Correction | 704-340151S | FDA UDI | Class II | Unknown |
| Smart Correction | 50-1054-20-WB | FDA UDI | Class II | Unknown |
| PRIMA Femoral Locking Plate System | 11-901-045022S-1 | FDA UDI | Class II | Active |
| Smart Correction | 50-1012-21A-WB | FDA UDI | Class II | Unknown |
| Smart Correction | 10-700-09058BA-0 | FDA UDI | Class II | Unknown |
| Smart Correction | 50-1031-01-WBNS | FDA UDI | Class II | Unknown |
| Smart Correction | 11-706-430200S | FDA UDI | Class II | Unknown |
| Smart Correction | 31-700-12038UA-0 | FDA UDI | Class II | Unknown |
| 3.5mm x 22mm Ti Cortical Screw | TCX35022 | FDA UDI | Class II | Active |
| Smart Correction | 11-705-420105S | FDA UDI | Class II | Unknown |
| EpiFIX | XK-EFC0222T-US | FDA UDI | Class II | Unknown |
| Smart Correction | 31-700-22528GA-0 | FDA UDI | Class II | Unknown |
| Smart Correction | 11-705-445151S | FDA UDI | Class II | Unknown |
| WishFIX | XK-EFC0216SS-08 | FDA UDI | Class II | Active |
| Smart Correction | 31-700-07006BA-0 | FDA UDI | Class II | Unknown |
Related Companies
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Wishbone Medical Inc. has three recall records listed in the FDA database, initiated between April 30, 2021, and April 5, 2024. The records include one classified, one open, and one terminated recall. The reasons cited involve a mechanical issue with strut adjustment, nonconformities in engineering specifications for implant plates and screws, and incorrect packaging where stainless-steel implants were shipped instead of titanium implants as indicated.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 5, 2024 | Z-1808-2024 | — | open, classified | The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated. |
| Jan 4, 2023 | Z-1102-2023 | — | open, classified | Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction. |
| Apr 30, 2021 | Z-1794-2021 | — | terminated | Nonconformities were discovered to the engineering specifications for implant plates and screws. |