# K032367: Itst Intertrochanteric Subtrochanteric Intramedullary Femoral Nail

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Aug 12, 2003 after 11 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K962561 (1996). 2 ancestors in all.
17 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965098: Intramedullary Nail System, Zimmer, Inc. (1997) Summary page 1.

## Most influential descendants
- K091566: Zimmer Natural Nail System Cephalomedullary Nails (2009), 16 descendants of its own
- K120715: Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short (2012), 10 descendants of its own
- K231114: Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System (2023), 4 descendants of its own
- K192312: Zimmer Natural Nail System Cephalomedullary Nails (2019), 4 descendants of its own
- K213328: Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System (2022), 3 descendants of its own

## Recalls of this device
- Feb 28, 2017 · Class II · Z-2565-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
- Feb 28, 2017 · Class II · Z-2563-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
- Feb 28, 2017 · Class II · Z-2564-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
- Feb 28, 2017 · Class II · Z-2562-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
- Jan 11, 2016 · Class II · Z-1153-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jan 11, 2016 · Class II · Z-1138-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jan 11, 2016 · Class II · Z-1112-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Oct 11, 2013 · Class II · Z-1012-2014: 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
- Oct 11, 2013 · Class II · Z-1014-2014: 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
- Oct 11, 2013 · Class II · Z-1013-2014: 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
- Jun 5, 2009 · Not classified · Z-1701-2009: Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa.
- Jun 5, 2009 · Not classified · Z-1702-2009: Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa.

## Indications for use
The ITST Intramedullary Nail is indicated for use in a variety of femoral fractures, such as: Subtrochanteric Fractures Intertrochanteric Fractures Comminuted Fractures Segmental Fractures Fractures with Bone Loss Proximal and Distal Fractures Nonunions

Source page: https://510kreport.com/device/K032367
Methodology: https://510kreport.com/methodology