510(k) K262722
- Device
- Primal K-Wire (P99-193-1410)
- Applicant
- Paragon 28, Inc.
- 510(k) number
- K262722
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-28
- Date received
- 2026-07-31
- Regulation
- 888.3040
- Classification name
- Pin, Fixation, Smooth
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Daniel Nelson
- Address
- 14445 Grasslands Dr. Centennial CO US 80112 80112
FDA Registration Numbers#
- 1000517406
- 2249529
- 3021393544
- 3009381600
- 2020601
- 8030965
- 1017294
- 3012966183
- 3002579136
- 3022472578
- 3007366790
- 3015212339
- 3017191784
- 3021226419
- 3012494290
- 3011580264
- 3006513362
- 3016496998
- 2936485
- 3017980495
- 8031020
- 3009971621
- 3015539532
- 3007109793
- 3006946279
- 3005536892
- 3015542154
- 2025102
- 3017196117
- 3014262693
- 3013176080
- 3008817603
- 3010673777
- 3015440604
- 3014315669
- 1835572
- 1032347
- 3036756245
- 3014680795
- 1226544
- 9613369
- 2245304
- 1220246
- 1834331
- 3004638532
- 1061927
- 3015946784
- 1043534
- 1226191
- 1220477
- 3005827567
- 2028632
- 3008951116
- 1221053
- 3010383847
- 3005641619
- 3006395932
- 3006498370
- 3000270450
- 2648666
- 1058584
- 9710629
- 2183946
- 3011500362
- 3011302692
- 3010329663
- 1319660
- 3020899789
- 3012818475
- 3020704423
- 1222773
- 1054811
- 9617297
- 3015967359
- 3009110133
- 3015231789
- 1020279
- 3007125392
- 3011137372
- 3014315560
Source Documents#
Other 510(k) Records For Product Code HTY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253325 | ZipToe™ Hammertoe Fusion System | Toetal Solutions | 2025-12-29 |
| K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. | 2025-09-19 |
| K250315 | RONAVIS – FX (FX-001) | AIRS, Inc. | 2025-08-01 |
| K251362 | PediFlex™ Flexible Nail System | OrthoPediatrics Corp. | 2025-06-24 |
| K250646 | Impact PEEK Union Nail System | Nvision Biomedical Technologies | 2025-06-11 |
| K241014 | Biomet Kirschner Wires (K-Wires) | Biomet, Inc. | 2024-05-22 |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail | OSSIO , Ltd. | 2023-12-01 |
| K231147 | Hammerdesis™ Interphalangeal Fusion System | Intelivation | 2023-09-14 |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation Nail | OSSIO , Ltd. | 2023-09-13 |
| K231905 | Electro-Spec Steri-Caps | Electro-Spec, Inc. | 2023-08-14 |
| K231339 | Tyber Medical Pin and Wire System (various) | Tyber Medical, LLC | 2023-07-06 |
| K221283 | Hammertoe Truss System (HTS) | 4Web Medical, Inc. | 2022-09-06 |
| K220906 | SECURE-LOCK | Xiros, Ltd. | 2022-07-22 |
| K213982 | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires | Pacific Instruments | 2022-02-17 |
| K211789 | restor3d Pin Implants | Restor3D | 2022-01-04 |