# K141385: Depuy Synthes Injectable Polymer System (Ips)

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Synthes Companies of Johnson & Johnson
- Decided: Mar 27, 2015 after 304 days
- Product code: HBW (Fastener, Plate, Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K904436 (1990). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050204: Synthes Rapid Resorbable Tack System, Synthes (Usa) (2005) Summary page 4.
- K062789: Synthes (Usa) Rapid Resorbable Fixation System, Synthes (Usa) (2007) Summary page 4.
- K080862: Sonicweld RX (Resorb-X), KLS-Martin L.P. (2008) Summary page 4.
- K992355: Lactosorb Trauma Plating System, Biomet, Inc. (1999) Summary page 4.

## Recalls of this device
- Jan 24, 2024 · Class II · Z-1238-2024: Products not sterilized, sterility cannot be confirmed

## Indications for use
The RAPIDSORB Injectable Polymer System (IPS) is intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. RAPIDSORB IPS fasteners are designed to be used for the fixation of RAPIDSORB plates, meshes, and sheets. In addition, RAPIDSORB IPS implants and instruments may be used with RAPIDSORB meshes and sheets in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in craniofacial reconstruction (excluding the upper and lower jaw).

Source page: https://510kreport.com/device/K141385
Methodology: https://510kreport.com/methodology