# K061499: Osferion

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Jan 26, 2007 after 240 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: 1 generation back to K994337 (2000). 2 ancestors in all.
73 later devices descend from it; 2 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013072: Chronos Tricalcium Prosphate (Chronos TCP), Synthes (2002) Summary page 2.
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 2.

## Most influential descendants
- K191974: NuVasive AttraX Putty (2019), 71 descendants of its own
- K203714: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty (2021), 66 descendants of its own
- K222276: CONDUIT Cages; FIBERGRAFT BG Putty (2022), 29 descendants of its own
- K223731: NuVasive Modulus-C Interbody System (2023), 11 descendants of its own
- K231735: NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System (2023), 9 descendants of its own

## Indications for use
OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K061499
Methodology: https://510kreport.com/methodology