FDA 510(k) ClearanceHRS
APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista
FDA 510(k) K252897 · A Plus Biotechnology Co., Ltd.
- 510(k) number
- K252897
- Device name
- APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista
- Applicant
- A Plus Biotechnology Co., Ltd.
- Product code
- HRS
- Decision
- Substantially Equivalent
- Decision date
- Device class
- Class 2
- Regulation number
- 888.3030
- Advisory committee
- OR
- Medical specialty
- Orthopedic
Candidate predicate devices
Other devices cleared under product code HRS form a screening cohort, not a predicate determination. Compare intended use, technological characteristics, performance evidence, labeling, and current legal-marketing status before selecting a predicate.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261406 | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | TriMed, Inc. | |
| K261191 | Alians Elbow S | Newclip Technics | |
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | |
| K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | |
| K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L | I.T.S. GmbH | |
| K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | |
| K260761 | APTUS Clavicle System 2.8 | Medartis AG | |
| K261002 | Pectus Blu System | Biomet Microfixation | |
| K261038 | Xpert PFP | Newclip Technics | |
| K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | |
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. |
Building a 510(k) around this device type?
Assyro turns predicate research into a substantial-equivalence comparison and an eSTAR-ready 510(k) workflow — so predicate strategy, testing evidence, and labeling stay aligned before FDA review.