# K051678: Synthes Hindfoot Arthrodesis Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 21, 2005 after 90 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 3 cite it directly.
0 of 17 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) Biomet Inc. - Titanium Ankle Arthrodesis Nail: named in the summary without a submission number
- (no number) Synthes - 6.0 mm Locking Screws (accessory in Titanium Distal Femoral Nail System): named in the summary without a submission number

## Most influential descendants
- K112982: Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail ) (2012), 11 descendants of its own
- K130147: Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail) (2013), 9 descendants of its own
- K182307: Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System (2019), 8 descendants of its own
- K192163: TTC Phantom® Intramedullary Nail System (2020), 6 descendants of its own
- K191782: TTC Phantom Intramedullary Nail System (2019), 6 descendants of its own

## Recalls of this device
- Jan 24, 2024 · Class II · Z-1234-2024: Products not sterilized, sterility cannot be confirmed

## Indications for use
The Synthes Hindfoot Arthrodesis Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include, but are not limited to Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.

Source page: https://510kreport.com/device/K051678
Methodology: https://510kreport.com/methodology