510(k) · Cleared
Recalled · Class II · 2019Zimmer M/DN Intramedullary Fixation 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 Oct 22, 2014 as substantially equivalent to K962561 (Zimmer, Inc., 1996) and 2 other predicates after a 68-day review. Its family tree reaches back 5 generations to 1997. 10 later devices descend from it. It has been recalled 7 times.
- Decided
- Oct 22, 2014
- Review
- 68 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 7
- Predicates
- 3
Its longest line of descent runs back 5 generations to K970097 (1997). 10 ancestors in all, the oldest K871539 (1987). 10 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 4 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 3 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 2 generations backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
- 1 generation backK101622 Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc. · 2010 · Recalled
- This deviceK142281 Zimmer M/DN Intramedullary Fixation SystemZimmer, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK181827 Affixus Natural Nail System Humeral NailZimmer GmbH · 2018
- Descendant · 2 generations on · 4 of its ownK231114 Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus®…Zimmer Switzerland Manufacturing GmbH · 2023
- Descendant · 3 generations on · 2 of its ownK241651 Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · Recalled
- Descendant · 2 generations on · 1 of its ownK200814 Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH · 2020
- Descendant · 4 generations on · 0 of its ownK253566 Affixus Retrograde Femoral Nailing SystemZimmer, Inc. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K181827Affixus Natural Nail System Humeral NailZimmer GmbH · 2018 · cites it directly6descendants
- K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH · 2023 · 2 generations on4descendants
- K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · 3 generations on2descendants
- K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH · 2020 · 2 generations on1descendant
- K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −4 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −3 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −2 | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | 2003 | — |
| −1 | K101622 | Zimmer Natural Nail System Retrograde Femoral Nails | Zimmer, Inc. | 2010 | 3 |
| 0 (this device) | K142281 | Zimmer M/DN Intramedullary Fixation System | Zimmer, Inc. | 2014 | — |
| +1 | K181827 | Affixus Natural Nail System Humeral Nail | Zimmer GmbH | 2018 | — |
| +2 | K231114 | Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail®… | Zimmer Switzerland Manufacturing GmbH | 2023 | — |
| +3 | K241651 | Affixus Tibial and Antegrade Femoral Nailing System | Zimmer, Inc. | 2024 | 17 |
| +2 | K200814 | Affixus (R) Natural Nail (R) System Humeral Nail | Zimmer GmbH | 2020 | — |
| +4 | K253566 | Affixus Retrograde Femoral Nailing System | Zimmer, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (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 5…ramedullary Fixation (21 CFR 888.3020, HSB) Classification Panel: Orthopedics/87 Predicate Device(s): Supracondylar Intramedullary Nail (Zimmer, K962561, cleared September 25, 1996), Intramedullary Nail System (Zimme… | 1996 |
| * | K965098 | Intramedullary Nail SystemSummary page 5…Intramedullary Nail (Zimmer, K962561, cleared September 25, 1996), Intramedullary Nail System (Zimmer, K965098, cleared February 28, 1997), Zimmer Natural Nail System Retrograde Femoral Nails (Zimmer,… | 1997 |
| * | K101622 | Zimmer Natural Nail System Retrograde Femoral NailsSummary page 5…mmer, K965098, cleared February 28, 1997), Zimmer Natural Nail System Retrograde Femoral Nails (Zimmer, K101622, cleared October 1, 2010) Purpose and Device This submission covers line extensions and labeling Description:… | 2010 |
What descends from it? (10)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181827 | Affixus Natural Nail System Humeral Nail | 2018 | 6 |
| K243907 | Affixus Tibial Nailing System - 4mm screws | 2025 | 0 |
| K210285 | Adaptable Ortho Innovations Intramedullary Nail System | 2021 | 0 |
| K191238 | Zimmer Guide Wire Devices | 2019 | 0 |
| K143321 | ITST Intertrochanteric/Subtrochanteric Fixation System | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0328-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Apr 28, 2017 | Class II | Z-2595-2017 | 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-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-2598-2017 | 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. |
| May 4, 2016 | Class II | Z-1678-2016 | Packaging change control | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. |
| Jan 11, 2016 | Class II | Z-1136-2016 | 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-1141-2016 | 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. |
The 5 latest of 7 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 17 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 7 of the 10 ancestors have a recall of any class.
- Of its descendants, K181827 (Zimmer GmbH, 2018) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K962561.
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. 2014, this device’s year, is highlighted.
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 femoral 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 The retrograde femoral nail is indicated for use in a variety of retrograde type femoral fractures, such as: – Closed Supracondylar Fractures – Severely Comminuted Supracondylar Fractures with Articular…
Read the full statement (258 words)
The femoral 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
The retrograde femoral nail is indicated for use in a variety of retrograde type femoral fractures, such as:
– Closed Supracondylar Fractures
– Severely Comminuted Supracondylar Fractures with Articular Involvement
– Nonunions or Pseudoarthroses
– Malunions
– Pathological Fractures
– Fractures without Extensive Comminution
– Distal Fractures Involving Osteoporotic Bone
– Fractures Involving the Femoral Condyles that Require Open Knee Access
– T-Condylar Fractures
– Femoral Shaft Fracture with Attendant Femoral Neck Fractures (Nail to be Used in Conjunction with Fixation Screws or Plates as Needed)
– Intertrochanteric Femoral Shaft Fractures
– Ipsilateral Femorotibial Fractures (“Floating Knee” Fractures)
– Femoral Shaft Fractures
– Bilateral Femoral Shaft Fractures
– Ipsilateral Patellofemoral Fractures
The tibial nail is indicated for use in a variety of tibial fractures, such as:
– Comminuted Fractures
– Segmental Fractures
– Fractures with Bone Loss
– Proximal and Distal Fractures
– Nonunions
– Transverse Fractures
– Oblique Fractures
– Spiral Fractures
– Bilateral Fractures
– Fractures with Butterfly Fragments
– Pseudarthrosis of the Tibial Shaft
– Corrective Osteotomies
The humeral nail is indicated for use in a variety of humeral fractures, such as:
– Comminuted Fractures
– Segmental Fractures
– Fractures with Bone Loss
– Proximal and Distal Fractures
– Nonunions
– Delayed Unions
– Pathological Fractures
– Floating Elbow
– Nerve Lesion
– Multiple Trauma Injuries
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142281: Zimmer M/DN Intramedullary Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142281
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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