Data / Medical devices / Wax, Bone
Wax, Bone (MTJ): 13 FDA-registered makers in 5 countries
13 establishments in 5 countries are registered with the FDA to make Wax, Bone (product code MTJ, Class U). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 43 510(k) clearances under this code, the latest on September 3, 2026, and lists 4 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- MTJ
- Device class
- U
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| United Kingdom | 1 |
| Mexico | 1 |
| India | 1 |
| Brazil | 1 |
Makers of Wax, Bone
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abyrx, Inc. | Stamford, CT, United States | Complaint file establishment, Manufacturer | 24 | September 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Apatech Ltd. | ELSTREE Hertfordshire, United Kingdom | Manufacturer | 6 | October 8, 2010 | 0 | 0 | 0 | api.fda.gov |
| Surgical Specialties Mexico S DE RL DE CV | Tijuana Baja California, Mexico | Manufacturer | 2 | March 9, 2005 | 0 | 0 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 2 | December 13, 2011 | 0 | 0 | 0 | api.fda.gov |
| Hemostasis Biomedical, LLC | Saint Paul, MN, United States | Manufacturer | 1 | January 23, 2015 | 0 | 0 | 0 | api.fda.gov |
| Meril Endo Surgery Pvt. Ltd. | Vapi Gujarat, India | Manufacturer | 1 | March 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Riverpoint Medical LLC | Portland, OR, United States | Complaint file establishment, Specification developer | 1 | June 19, 2003 | 0 | 0 | 0 | api.fda.gov |
| Theragenics Corp. | Buford, GA, United States | Specification developer | 1 | November 2, 2006 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, Inc. | Somerville, NJ, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Ethicon, Inc. | Raritan, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon, LLC | Guaynabo, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Filltech Usa, LLC | Rockwell, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Johnson & Johnson do Brasil Ind. Com. de Prod. p/ Saude Ltda | SAO JOSE DOS CAMPOS Sao Paulo, Brazil | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.