# K001046: Biopro Glenoid Component W/ Keel & W/ Posts

- Pathway: 510(k) (Traditional)
- Applicant: Biopro, Inc.
- Decided: Jun 8, 2000 after 69 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K092474: Pyrenees Cervical Plate System, Semi-Constrained Screws (2010), 8 descendants of its own
- K152281: Pyrenees Cervical Plate System (2015), 6 descendants of its own
- K172104: Ozark (tm) Cervical Plate System (2017), 5 descendants of its own
- K182473: PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems (2018), 4 descendants of its own
- K242361: OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI (2024), 1 descendant of its own

Source page: https://510kreport.com/device/K001046
Methodology: https://510kreport.com/methodology