# K962561: Supracondylar Intramedullary Nail

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Sep 25, 1996 after 86 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.
77 later devices descend from it; 3 cite it directly.
0 of 78 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) Intramedullary Supracondylar Nail: named in the summary without a submission number
- (no number) AIM Supracondylar Nail: named in the summary without a submission number

## Most influential descendants
- K965098: Intramedullary Nail System (1997), 75 descendants of its own
- K083497: Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails (2009), 39 descendants of its own
- K082770: Zimmer Natural Nail System Tibial Nail (2008), 35 descendants of its own
- K101622: Zimmer Natural Nail System Retrograde Femoral Nails (2010), 29 descendants of its own
- K172774: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 17 descendants of its own

## Recalls of this device
- Oct 11, 2013 · Class II · Z-1008-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag

## Indications for use
The Supracondylar Nail is intended for use in fixation of various types of fractures of the supracondylar or distal region of the femur as well as for proximal fractures in conjunction with supracondylar fractures.

Source page: https://510kreport.com/device/K962561
Methodology: https://510kreport.com/methodology