510(k) · Cleared
Recalled · Class II · 2017Itst Intertrochanteric Subtrochanteric Intramedullary Femoral Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Aug 12, 2003 as substantially equivalent to K965098 (Zimmer, Inc., 1997) after an 11-day review. Its family tree reaches back 2 generations to 1996. 17 later devices descend from it. It has been recalled 12 times.
- Decided
- Aug 12, 2003
- Review
- 11 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 12
- Predicates
- 1
Its longest line of descent runs back 2 generations to K962561 (1996). 17 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK962561 Supracondylar Intramedullary NailZimmer, Inc. · 1996 · Recalled
- 1 generation backK965098 Intramedullary Nail SystemZimmer, Inc. · 1997 · Recalled
- This deviceK032367 Itst Intertrochanteric Subtrochanteric Intramedullary Femoral NailZimmer, Inc. · 2003
- Descendant · cites it directly · 16 of its ownK091566 Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH · 2009 · Recalled
- Descendant · 2 generations on · 10 of its ownK120715 Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortZimmer GmbH · 2012
- Descendant · 2 generations on · 4 of its ownK231114 Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus®…Zimmer Switzerland Manufacturing GmbH · 2023
- Descendant · 2 generations on · 4 of its ownK192312 Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH · 2019
- Descendant · 3 generations on · 3 of its ownK213328 Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing…Stryker GmbH · 2022 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K091566Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH · 2009 · cites it directly16descendants
- K120715Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortZimmer GmbH · 2012 · 2 generations on10descendants
- K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH · 2023 · 2 generations on4descendants
- K192312Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH · 2019 · 2 generations on4descendants
- K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH · 2022 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962561 | Supracondylar Intramedullary Nail | Zimmer, Inc. | 1996 | 1 |
| −1 | K965098 | Intramedullary Nail System | Zimmer, Inc. | 1997 | 29 |
| 0 (this device) | K032367 | Itst Intertrochanteric Subtrochanteric Intramedullary Femoral Nail | Zimmer, Inc. | 2003 | — |
| +1 | K091566 | Zimmer Natural Nail System Cephalomedullary Nails | Zimmer GmbH | 2009 | 5 |
| +2 | K120715 | Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short | Zimmer GmbH | 2012 | — |
| +2 | K231114 | Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail®… | Zimmer Switzerland Manufacturing GmbH | 2023 | — |
| +2 | K192312 | Zimmer Natural Nail System Cephalomedullary Nails | Zimmer GmbH | 2019 | — |
| +3 | K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System | Stryker GmbH | 2022 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HSB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K965098 | Intramedullary Nail SystemSummary page 1…21 CFR 6 888.3020 Predicate Device: M/DN Intramedullary Fixation System, manufactured by Zimmer, K965098, cleared February 28, 1997. Device Description: The ITST is used to pr… | 1997 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091566 | Zimmer Natural Nail System Cephalomedullary Nails | 2009 | 16 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2017 | Class II | Z-2565-2017 | Packaging | 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 | Packaging | 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 | Packaging | 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 | Packaging | 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 | Packaging | 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 | Packaging | 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 | Packaging | 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 | Packaging | 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 packaging operations conducted in the… |
| Oct 11, 2013 | Class II | Z-1014-2014 | Packaging | 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 packaging operations conducted in the… |
| Oct 11, 2013 | Class II | Z-1013-2014 | Packaging | 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 packaging operations conducted in the… |
| Jun 5, 2009 | Not classified | Z-1701-2009 | Process control | 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 | Process control | Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa. |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 6.5 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K091566 (Zimmer GmbH, 2009) has gone furthest, with 16 descendants of its own.
- 8 other devices also cite its predicate K965098.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032367 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032367: Itst Intertrochanteric Subtrochanteric Intramedullary Femoral Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032367
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026