# K062789: Synthes (Usa) Rapid Resorbable Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Feb 27, 2007 after 162 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 7 cite it directly.
0 of 14 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) Synthes (USA) Rapid Resorbable Tack System: named in the summary without a submission number
- (no number) Synthes (USA) Poly (L-Lactide-co-Glycolide) Resorbable Fixation System: named in the summary without a submission number
- (no number) Synthes (USA) Rapid Resorbable Cranial Clamp: named in the summary without a submission number
- (no number) Biomet, Inc., Lactosorb Trauma Plating System: named in the summary without a submission number

## Most influential descendants
- K132920: Spirox Inex Device (2014), 4 descendants of its own
- K080862: Sonicweld RX (Resorb-X) (2008), 4 descendants of its own
- K223167: Spirair Nasal Septal Strap (2023), 3 descendants of its own
- K233569: SeptAlign (2024), 2 descendants of its own
- K112064: Resorb X-G (2012), 2 descendants of its own

## Recalls of this device
- May 2, 2016 · Class II · Z-1919-2016: Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
- May 2, 2016 · Class II · Z-1920-2016: Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
- May 2, 2016 · Class II · Z-1918-2016: Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

## Indications for use
The Synthes (USA) Rapid Resorbable Fixation System is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, sheets, screws and tacks may be used 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 reconstruction of the craniofacial or mandibular areas.

Source page: https://510kreport.com/device/K062789
Methodology: https://510kreport.com/methodology