EpiFIX
Procedure Kit, Curved 4-Hole X 22mm EpiFIX Plate, Instruments and Solid Screws, Ti
2manufacturers in China registered for this device type
240catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
Record
| Listed by | Wishbone Medical Inc., United States |
|---|---|
| FDA product code | OBT |
| Device type | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K182704 |
| Record published | 2021-06-30 |
| Record revised | 2025-11-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2021-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TEFCS28-US | Withdrawn | |
| XK-EFC0222SS | Withdrawn | |
| EFC0216S-US | Withdrawn | |
| TEFSS36 | Withdrawn | |
| XK-EFC0212ST-US | Withdrawn | |
| XK-EFC0222ST-US | Withdrawn | |
| PK-EFC0422ST-US | Withdrawn | |
| PK-EFC0216SS | Withdrawn | |
| XK-EFC0432ST | Withdrawn | |
| XK-EFC0426S-US | Withdrawn | |
| SEFSS16 | Withdrawn | |
| PK-EFC0416ST | Withdrawn | |
| SEFCS16-US | Withdrawn | |
| XK-EFC0422ST-US | Withdrawn | |
| TEFCS32-US | Withdrawn | |
| XK-EFC0416SS-US | Withdrawn | |
| XK-EFC0426S | Withdrawn | |
| XK-EFC0432ST-US | Withdrawn | |
| EFC0220S-US | Withdrawn | |
| XK-EFC0216SS | Withdrawn | |
| XK-EFC0212T | Withdrawn | |
| XK-EFC0426T | Withdrawn | |
| TEFSS16-US | Withdrawn | |
| SEFSS32-US | Withdrawn | |
| SEFCS20 | Withdrawn | |
| XK-EFC0222ST | Withdrawn | |
| TEFSS28 | Withdrawn | |
| XK-EFC0222S | Withdrawn | |
| PK-EFC0432ST-US | Withdrawn | |
| XK-EFC0220ST-US | Withdrawn | |
| XK-EFC0422T | Withdrawn | |
| PK-EFC0416S-US | Withdrawn | |
| XK-EFC0416SS | Withdrawn | |
| PK-EFC0222ST-US | Withdrawn | |
| XK-EFC0414SS-US | Withdrawn | |
| XK-EFC0216ST-US | Withdrawn | |
| EFC0414S-US | Withdrawn | |
| SEFSS28-US | Withdrawn | |
| TEFSS24-US | Withdrawn | |
| TEFSS20-US | Withdrawn | |
| EFC0212S | Withdrawn | |
| PK-EFC0216S | Withdrawn | |
| PK-EFC0224T | Withdrawn | |
| PK-EFC0432T-US | Withdrawn | |
| TEFCS24 | Withdrawn | |
| XK-EFC0416ST-US | Withdrawn | |
| XK-EFC0212S-US | Withdrawn | |
| SEFCS20-US | Withdrawn | |
| XK-EFC0216S | Withdrawn | |
| PK-EFC0426SS-US | Withdrawn | |
| XK-EFC0414ST-US | Withdrawn | |
| XK-EFC0414SS | Withdrawn | |
| PK-EFC0414S-US | Withdrawn | |
| XK-EFC0426T-US | Withdrawn | |
| XK-EFC0416ST | Withdrawn | |
| PK-EFC0220S | Withdrawn | |
| PK-EFC0432T | Withdrawn | |
| PK-EFC0212S | Withdrawn | |
| EFC0426T | Withdrawn | |
| PK-EFC0220SS-US | Withdrawn | |
| SEFCS24-US | Withdrawn | |
| EFC0224T-US | Withdrawn | |
| EFC0220T-US | Withdrawn | |
| PK-EFC0416SS | Withdrawn | |
| PK-EFC0222S | Withdrawn | |
| EFC0422T | Withdrawn | |
| SEFCS24 | Withdrawn | |
| EFC0220S | Withdrawn | |
| PK-EFC0222ST | Withdrawn | |
| PK-EFC0216S-US | Withdrawn | |
| PK-EFC0416T-US | Withdrawn | |
| PK-EFC0416SS-US | Withdrawn | |
| PK-EFC0422S-US | Withdrawn | |
| PK-EFC0422SS | Withdrawn | |
| SEFCS32-US | Withdrawn | |
| PK-EFC0216ST | Withdrawn | |
| XK-EFC0216S-US | Withdrawn | |
| PK-EFC0422S | Withdrawn | |
| SEFCS36-US | Withdrawn | |
| XK-EFC0224S | Withdrawn | |
| EFC0422T-US | Withdrawn | |
| XK-EFC0212T-US | Withdrawn | |
| XK-EFC0414S | Withdrawn | |
| XK-EFC0426ST-US | Withdrawn | |
| TEFCS36-US | Withdrawn | |
| EFC0220T | Withdrawn | |
| PK-EFC0432S-US | Withdrawn | |
| XK-EFC0222T-US | Withdrawn | |
| EFC0216T-US | Withdrawn | |
| XK-EFC0432SS-US | Withdrawn | |
| EFC0426S | Withdrawn | |
| TEFCS28 | Withdrawn | |
| PK-EFC0414ST-US | Withdrawn | |
| XK-EFC0422SS | Withdrawn | |
| EFC0222T-US | Withdrawn | |
| EFC0224T | Withdrawn | |
| PK-EFC0224ST-US | Withdrawn | |
| XK-EFC0432SS | Withdrawn | |
| EFC0426S-US | Withdrawn | |
| PK-EFS0432SS | Withdrawn | |
| XK-EFC0224ST-US | Withdrawn | |
| SEFSS16-US | Withdrawn | |
| PK-EFC0220T | Withdrawn | |
| TEFCS16-US | Withdrawn | |
| PK-EFC0212ST | Withdrawn | |
| SEFSS32 | Withdrawn | |
| XK-EFC0222T | Withdrawn | |
| PK-EFC0224SS | Withdrawn | |
| PK-EFC0222SS | Withdrawn | |
| XK-EFC0414S-US | Withdrawn | |
| SEFCS28 | Withdrawn | |
| EFC0416T | Withdrawn | |
| XK-EFC0422ST | Withdrawn | |
| EFC0414S | Withdrawn | |
| PK-EFC0224S | Withdrawn | |
| PK-EFC0422ST | Withdrawn | |
| XK-EFC0216ST | Withdrawn | |
| PK-EFC0224S-US | Withdrawn | |
| PK-EFC0426SS | Withdrawn | |
| XK-EFC0224T | Withdrawn | |
| EFC0416S-US | Withdrawn | |
| XK-EFC0216T | Withdrawn | |
| PK-EFC0432ST | Withdrawn | |
| SEFSS36 | Withdrawn | |
| SEFSS20 | Withdrawn | |
| XK-EFC0216T-US | Withdrawn | |
| PK-EFC0216ST-US | Withdrawn | |
| XK-EFC0220T-US | Withdrawn | |
| TEFSS32 | Withdrawn | |
| EFC0422S-US | Withdrawn | |
| PK-EFC0220S-US | Withdrawn | |
| XK-EFC0220SS | Withdrawn | |
| XK-EFC0432T | Withdrawn | |
| TEFCS20-US | Withdrawn | |
| PK-EFC0222T-US | Withdrawn | |
| EFC0414T-US | Withdrawn | |
| SEFCS36 | Withdrawn | |
| XK-EFC0212SS | Withdrawn | |
| EFC0422S | Withdrawn | |
| PK-EFC0216SS-US | Withdrawn | |
| EFC0212T-US | Withdrawn | |
| EFC0432S | Withdrawn | |
| PK-EFC0416T | Withdrawn | |
| PK-EFC0414ST | Withdrawn | |
| TEFSS24 | Withdrawn | |
| XK-EFC0426SS-US | Withdrawn | |
| PK-EFC0414T-US | Withdrawn | |
| PK-EFC0220T-US | Withdrawn | |
| SEFSS24 | Withdrawn | |
| PK-EFC0224T-US | Withdrawn | |
| PK-EFC0212SS | Withdrawn | |
| PK-EFC0426S-US | Withdrawn | |
| EFC0222T | Withdrawn | |
| XK-EFC0224SS | Withdrawn | |
| PK-EFC0220ST | Withdrawn | |
| EFC0426T-US | Withdrawn | |
| PK-EFC0414SS | Withdrawn | |
| XK-EFC0416S-US | Withdrawn | |
| XK-EFC0222S-US | Withdrawn | |
| XK-EFC0414ST | Withdrawn | |
| TEFSS16 | Withdrawn | |
| XK-EFC0432S-US | Withdrawn | |
| XK-EFC0224S-US | Withdrawn | |
| TEFCS36 | Withdrawn | |
| PK-EFC0416ST-US | Withdrawn | |
| EFC0414T | Withdrawn | |
| SEFCS28-US | Withdrawn | |
| XK-EFC0426ST | Withdrawn | |
| TEFSS20 | Withdrawn | |
| PK-EFC0224ST | Withdrawn | |
| PK-EFS0432SS-US | Withdrawn | |
| EFC0416S | Withdrawn | |
| SEFSS20-US | Withdrawn | |
| XK-EFC0220SS-US | Withdrawn | |
| SEFCS32 | Withdrawn | |
| XK-EFC0426SS | Withdrawn | |
| XK-EFC0224T-US | Withdrawn | |
| EFC0224S-US | Withdrawn | |
| XK-EFC0432S | Withdrawn | |
| PK-EFC0224SS-US | Withdrawn | |
| TEFCS16 | Withdrawn | |
| SEFSS24-US | Withdrawn | |
| PK-EFC0414T | Withdrawn | |
| EFC0212T | Withdrawn | |
| EFC0222S | Withdrawn | |
| XK-EFC0422T-US | Withdrawn | |
| XK-EFC0212SS-US | Withdrawn | |
| SEFSS28 | Withdrawn | |
| EFC0216S | Withdrawn | |
| PK-EFC0414S | Withdrawn | |
| PK-EFC0212ST-US | Withdrawn | |
| XK-EFC0224ST | Withdrawn | |
| XK-EFC0416T-US | Withdrawn | |
| PK-EFC0220ST-US | Withdrawn | |
| EFC0416T-US | Withdrawn | |
| XK-EFC0216SS-US | Withdrawn | |
| PK-EFC0222SS-US | Withdrawn | |
| TEFSS36-US | Withdrawn | |
| PK-EFC0426ST-US | Withdrawn | |
| EFC0222S-US | Withdrawn | |
| XK-EFC0220S | Withdrawn | |
| EFC0212S-US | Withdrawn | |
| TEFSS28-US | Withdrawn | |
| EFC0432T-US | Withdrawn | |
| XK-EFC0220ST | Withdrawn | |
| PK-EFC0212S-US | Withdrawn | |
| XK-EFC0212ST | Withdrawn | |
| EFC0224S | Withdrawn | |
| XK-EFC0224SS-US | Withdrawn | |
| PK-EFC0414SS-US | Withdrawn | |
| XK-EFC0212S | Withdrawn | |
| XK-EFC0220T | Withdrawn | |
| PK-EFC0222T | Withdrawn | |
| XK-EFC0416S | Withdrawn | |
| PK-EFC0422SS-US | Withdrawn | |
| PK-EFC0426S | Withdrawn | |
| XK-EFC0220S-US | Withdrawn | |
| PK-EFC0432S | Withdrawn | |
| SEFCS16 | Withdrawn | |
| PK-EFC0222S-US | Withdrawn | |
| EFC0432S-US | Withdrawn | |
| EFC0432T | Withdrawn | |
| PK-EFC0426ST | Withdrawn | |
| XK-EFC0422SS-US | Withdrawn | |
| TEFCS20 | Withdrawn | |
| XK-EFC0422S-US | Withdrawn | |
| XK-EFC0416T | Withdrawn | |
| SEFSS36-US | Withdrawn | |
| XK-EFC0222SS-US | Withdrawn | |
| XK-EFC0414T | Withdrawn | |
| TEFSS32-US | Withdrawn | |
| TEFCS24-US | Withdrawn | |
| PK-EFC0220SS | Withdrawn | |
| EFC0216T | Withdrawn | |
| TEFCS32 | Withdrawn | |
| PK-EFC0212SS-US | Withdrawn | |
| XK-EFC0432T-US | Withdrawn | |
| XK-EFC0414T-US | Withdrawn | |
| PK-EFC0416S | Withdrawn | |
| XK-EFC0422S | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| WishFIX | Wishbone Medical Inc. | 248 |
| WishFIX | RED Star Contract Manufacturing Inc. | 124 |
| Guided Growth Plate System | Orthofix SRL | 42 |
| Giro Growth Modulation System | Orthopediatrics Canada ULC | 35 |
| Procedure Kit, Curved 4 hole x 22mm EpiFIX Plate, Instruments and Screws, Ti | Wishbone Medical Inc. | 2 |
| Procedure Kit, Curved 2 hole x 16mm EpiFIX Plate, Instruments and Screws, Ti | Wishbone Medical Inc. | 2 |
| Procedure Kit, Curved 4 hole x 26mm EpiFIX Plate, Instruments and Screws, Ti | Wishbone Medical Inc. | 2 |
| Procedure Kit, Curved 2 hole x 12mm EpiFIX Plate, Instruments and Screws, Ti | Wishbone Medical Inc. | 2 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182704 | 2019-06-25 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Wishbone Medical Inc. | 510(k) number | 2024-04-05 | Class II | Nonconforming Material/Component | 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. | 60 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.