# K982953: Titanium Intramedullary Nails-Various Styles

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 21, 1998 after 58 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
121 later devices descend from it; 12 cite it directly.
0 of 122 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) Stainless steel intramedullary rods: named in the summary without a submission number
- (no number) Grosse Kempf System (Howmedica): named in the summary without a submission number
- (no number) Intramedullary Nails (Zimmer): named in the summary without a submission number
- (no number) Kirschner Intramedullary Nail System (now Biomet, Inc.): named in the summary without a submission number
- (no number) OEC Kuntscher Cloverleaf Nail Systems (now Biomet, Inc.): named in the summary without a submission number

## Most influential descendants
- K023115: Ace Versanail (2002), 41 descendants of its own
- K063570: Biomet Tibial Locking Nail System (2007), 37 descendants of its own
- K021786: Titanium Ankle Arthrodesis Nail (2002), 27 descendants of its own
- K101934: Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222, 1200-02-46XX, 2200-01-0000 (2011), 25 descendants of its own
- K113828: Dynanail Ankle Arthrodesis Nail (2012), 24 descendants of its own

## Recalls of this device
- Apr 2, 2009 · Not classified · Z-2289-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2288-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Mar 27, 2009 · Not classified · Z-2116-2009: Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.
- Mar 16, 2005 · Not classified · Z-0918-05: The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire.

## Indications for use
Intramedullary rods made of titanium alloy are used for the same indications as stainless steel intramedullary rods that have been commercially available continually since the 1950s. These devices are to be implanted into the long bones for alignment, stabilization and fixation of fractures caused by trauma or disease, the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis. Intramedullary rods are used in the femur, tibia, fibula, humerus, radius, and ulna.

Source page: https://510kreport.com/device/K982953
Methodology: https://510kreport.com/methodology