# K972196: Osteo Anatomical Bone Plates

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Aug 25, 1997 after 76 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bone plates offered by Waldemar Link GmbH & Co.: named in the summary without a submission number
- (no number) Bone plates offered by Synthes: named in the summary without a submission number
- (no number) Bone plates offered by Osteo AG: named in the summary without a submission number

## Most influential descendants
- K982545: BMP Cable System (1998), 17 descendants of its own
- K031162: Smith & Nephew Orthopaedic Cabling System (2003), 10 descendants of its own
- K203405: EVOS Large Fragment Plating System (2021), 3 descendants of its own
- K213126: Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws (2022), 2 descendants of its own
- K223762: Smith & Nephew ACCORD™ Cable System (2023), 1 descendant of its own

## Indications for use
The indications for the use of these bone plates, in keeping with those of other legally marketed bone plates, are as follows. The Osteo Anatomical Bone Plates are intended for internal fracture fixation of various long bones.

Source page: https://510kreport.com/device/K972196
Methodology: https://510kreport.com/methodology