# K013072: Chronos Tricalcium Prosphate (Chronos TCP)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes
- Decided: Nov 26, 2002 after 439 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
No predicates in its family tree.
137 later devices descend from it; 6 cite it directly.
0 of 138 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) Pro Osteon 500R Resorbable Bone Void Filler: named in the summary without a submission number
- (no number) Vitoss Scaffold Synthetic Bone Void filler: named in the summary without a submission number

## Most influential descendants
- K061499: Osferion (2007), 73 descendants of its own
- 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
- K032409: Vitoss Scaffold Synthetic Cancellous Bone Void Filler (2003), 55 descendants of its own
- K083033: Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft Substitute (2008), 47 descendants of its own

## Indications for use
Synthes ChronOS is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. ChronOS is indicated for use in the treatment of bony defects created surgically or through traumatic injury. ChronOS Tricalcium Phosphate is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis). 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/K013072
Methodology: https://510kreport.com/methodology