# K030989: Osteosorb Tack Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Noviace Corporation
- Decided: Apr 1, 2004 after 370 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- 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 K022035 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022035: Osteomedics Resorbable Small Fixation System, Osteosorb, Osteomedics, Inc. (2003) Summary page 1.

## Indications for use
The OstcoSorb® Tack Fixation System is intended for fractures of craniofacial skeleton including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbital area, comminuted fractures of the frontal sinus wall, and midfacial fractures; and reconstructive procedures of the midface or craniofacial skeleton. The OsteoSorb® Tack Fixation System stabilizes bone during healing in conjunction with appropriate postoperative immobilization. The OsteoSorb® Tack Fixation System stabilizes bone during healing in conjunction with appropriate postoperative immobilization. The Osteomedics® Resorbable Tack Fixation System is not intended for use in and is contraindicated for: 1) Significant comminuted fractures or area with active infection, 2) Patient conditions including: blood supply limitation, insufficient quantity or quality of bone, or latent infections and where patient co-operation can not be guaranteed (e.g. alcoholism). 3) Mandibular tumor resection. 4) Intermaxillary fixation without an appropriate external fixation by other means. 5) This device is not designed for use in the mandible or for use in full load bearing procedures.6) when time to healing is anticipated to be greater than six weeks, and when patient has a history of adverse reaction to resorbable materials (e.g. resorbable sutures). The OsteoSorb® Smooth Pin Fixation System intended for use in the presence of appropriate immobilization for the internal fixation of fractured non-load bearing bones, osteotomies and arthrodeses, for example in fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments. Correction of hallux valgus and repair of metacarpal and phalageal fusion and fracture. The OsteoSorb® Pin Fixation System stabilizes bone during healing in conjunction with appropriate postoperative immobilization. Use is contraindicated in case where conservative (closed) treatment is appropriate, where pressure osteosynthesis is desired, where fragments are subjected to tension stress, when time to healing is anticipated to be greater than six weeks, when patient has a history of adverse reaction to resorbable materials (e.g. resorbable sutures), when use of the device without appropriate postoperative immobilization, when fractures and osteotomies is in weight bearing bone, where internal fixation is otherwise contraindicated, e.g., insufficient quantity or quality of bone and where patient co-operation cannot be guaranteed (e.g. alcoholism) where significant comminuted fractures or area with active infection. Federal (USA) laws restrict this device to sale or on the order of a physician. The Noviace HeatingPen is used for plate bending and cutting plate, screw tip and pin. The HeatingPen device enables to mold in-situ OsteoSorb Plates to varying skeleton morphologies. The HeatingPen is a single-use, cordless and battery operated. Three (3) tips are provided - a cautery tip which is used to cut plates, screw tips and pins, a long malleable plate tip, and a short fixed plate tip, both of which will bend plates in-situ. The Noviace HeatingBath is used to shape intra-operatively the OsteoSorb® Plate and Mesh. The Noviace™ HeatingBath is consisting of heating unit and auxiliary pan, which are fabricated from PolarWare 304 Stainless Steel. The heating unit sold non-sterilized but the auxiliary pan is sold sterilized.

Source page: https://510kreport.com/device/K030989
Methodology: https://510kreport.com/methodology