510(k) · Cleared
Recalled · Class II · 2017Intramedullary Nail System
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 Feb 28, 1997 as substantially equivalent to K962561 (Zimmer, Inc., 1996) after a 70-day review. Its family tree reaches back 1 generation to 1996. 75 later devices descend from it. It has been recalled 29 times.
- Decided
- Feb 28, 1997
- Review
- 70 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 29
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962561 (1996). 75 later devices descend from it, 9 citing it directly.
- Root · 1 generation backK962561 Supracondylar Intramedullary NailZimmer, Inc. · 1996 · Recalled
- This deviceK965098 Intramedullary Nail SystemZimmer, Inc. · 1997
- Descendant · cites it directly · 39 of its ownK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
- Descendant · cites it directly · 35 of its ownK082770 Zimmer Natural Nail System Tibial NailZimmer, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 17 of its ownK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018
- Descendant · cites it directly · 17 of its ownK032367 Itst Intertrochanteric Subtrochanteric Intramedullary Femoral NailZimmer, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 16 of its ownK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
2003high 8 (2025) · low 0 (2004)2026
Most influential descendants
Showing 5 of 75 · See all- K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsZimmer, Inc. · 2009 · cites it directly39descendants
- K082770Zimmer Natural Nail System Tibial NailZimmer, Inc. · 2008 · cites it directly35descendants
- K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH · 2018 · 2 generations on17descendants
- K032367Itst Intertrochanteric Subtrochanteric Intramedullary Femoral NailZimmer, Inc. · 2003 · cites it directly17descendants
- K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH · 2018 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962561 | Supracondylar Intramedullary Nail | Zimmer, Inc. | 1996 | 1 |
| 0 (this device) | K965098 | Intramedullary Nail System | Zimmer, Inc. | 1997 | — |
| +1 | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade… | Zimmer, Inc. | 2009 | 16 |
| +1 | K082770 | Zimmer Natural Nail System Tibial Nail | Zimmer, Inc. | 2008 | 15 |
| +2 | K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN… | Stryker Trauma GmbH | 2018 | — |
| +1 | K032367 | Itst Intertrochanteric Subtrochanteric Intramedullary Femoral Nail | Zimmer, Inc. | 2003 | 12 |
| +2 | K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System… | Stryker Trauma GmbH | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2025 | 8 | 0 |
| 2026 | 7 | 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? (3)
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 |
|---|---|---|---|
| * | K962561 | Supracondylar Intramedullary NailSummary page 2…ullary Nail, manufactured by Smith and Nephew Richards, Inc. ' 318 % A Bristol-Myers Squibb Company - Supracondylar Nail, manufactured by Zimmer, Inc., K962561, cleared September 25, 1996 Device Description The Intramedullary Nail System is a series of cannulated intramedullary rods and… | 1996 |
| * | — | Kuntscher Nail Named without a submission number | |
| * | — | Russell-Taylor Intramedullary Nail Named without a submission number |
What descends from it? (75)
See all 759 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails | 2009 | 39 |
| K082770 | Zimmer Natural Nail System Tibial Nail | 2008 | 35 |
| K032367 | Itst Intertrochanteric Subtrochanteric Intramedullary Femoral Nail | 2003 | 17 |
| K091566 | Zimmer Natural Nail System Cephalomedullary Nails | 2009 | 16 |
| K111056 | Piccolo Composite Nailing System | 2011 | 15 |
| K142281 | Zimmer M/DN Intramedullary Fixation System | 2014 | 10 |
| K120715 | Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short | 2012 | 10 |
| K181827 | Affixus Natural Nail System Humeral Nail | 2018 | 6 |
| K090596 | Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and… | 2009 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 28, 2017 | Class II | Z-2597-2017 | Under Investigation by firm | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. |
| Apr 28, 2017 | Class II | Z-2596-2017 | Under Investigation by firm | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. |
| Feb 28, 2017 | Class II | Z-2569-2017 | 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-2554-2017 | 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-2572-2017 | 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-2568-2017 | 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-2555-2017 | 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-2559-2017 | 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-2570-2017 | 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-2557-2017 | 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-2556-2017 | 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-2567-2017 | 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-2571-2017 | 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-2561-2017 | 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-2552-2017 | 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-2560-2017 | 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-2553-2017 | 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-2573-2017 | 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-2558-2017 | 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-2551-2017 | 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-2549-2017 | 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-2550-2017 | 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-1158-2016 | 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-1140-2016 | 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-1135-2016 | 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-1011-2014 | 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-1008-2014 | 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-1009-2014 | 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… |
| Mar 16, 2004 | Not classified | Z-1004-04 | Other | One and possibly more units in the lot have the proximal angled hole oriented 180 degrees reversed from the required orientation. |
The 5 latest of 29 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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
2007high 23 (2017) · low 8 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
2007high 195 (2024) · low 57 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
2007high 81 (2009) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
2007high 4,111 (2021) · low 162 (2007)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?
Femoral and Tibial Nails
The Intramedullary Nail System femoral and tibial nails are indicated for use in fixation of femoral fractures including subtrochanteric, intertrochanteric, comminuted or segmental fractures, as well as fractures with bone loss, proximal and distal fractures, and nonunions.
Humeral Nail
The humeral Nail is indicated for comminuted fractures, segmental fractures, fractures with bone loss proximal and distal fractures, as well as nonunions, delayed unions, pathological fractures, floating elbow, nerve lesion, and multiple trauma injuries
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965098 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965098: Intramedullary Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965098
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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