# K041089: Oss Bone Graft System and Oss Rapidset Bone Graft System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Aug 31, 2004 after 127 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K990290 (1999). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990290: Craniofacial Calcium Phosphate Ceramic Bone Filler, Biomet, Inc. (1999) Summary page 1.
- K012569: Modification to: Injectable Mimix, Biomet, Inc. (2001) Summary page 1.
- K023718: Quickset Mimix Bone Void Filler, Walter Lorenz Surgical, Inc. (2002) Summary page 1.
- K003494: Mimix Bone Replacement System, Biomet, Inc. (2001) Summary page 1.
- K011048: BSM Bone Substitute Material, DePuy Orthopaedics, Inc. (2001)
- K011897: Norian SRS Bone Void Filler, Synthes (Usa) (2001) Summary page 1.
- K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute, Interpore Cross Intl. (1999) Summary page 1.

## Indications for use
The OSS Bone Graft System and the OSS RapidSet Bone Graft System are indicated for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure.

Source page: https://510kreport.com/device/K041089
Methodology: https://510kreport.com/methodology