510(k) · Cleared
ClearedHolland Femoral Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Dec 4, 1998 after a 49-day review. The FDA summary names its predicate without a number. 31 later devices descend from it.
- Decided
- Dec 4, 1998
- Review
- 49 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 3 citing it directly.
- This deviceK983641 Holland Femoral Nail SystemBiomet, Inc. · 1998
- Descendant · cites it directly · 22 of its ownK072161 Biomet Femoral Locking Nail SystemBiomet Manufacturing Corp · 2007 · Recalled
- Descendant · 2 generations on · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
- Descendant · cites it directly · 7 of its ownK050118 Ebi Trochanteric Nail SystemEbi, L.P. · 2005 · Recalled
- Descendant · 2 generations on · 6 of its ownK120148 Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc. · 2012
- Descendant · 2 generations on · 6 of its ownK083726 Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp. · 2009 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K072161Biomet Femoral Locking Nail SystemBiomet Manufacturing Corp · 2007 · cites it directly22descendants
- K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · 2 generations on10descendants
- K050118Ebi Trochanteric Nail SystemEbi, L.P. · 2005 · cites it directly7descendants
- K120148Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc. · 2012 · 2 generations on6descendants
- K083726Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp. · 2009 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983641 | Holland Femoral Nail System | Biomet, Inc. | 1998 | — |
| +1 | K072161 | Biomet Femoral Locking Nail System | Biomet Manufacturing Corp | 2007 | 8 |
| +2 | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral… | I.T.S. GmbH | 2014 | — |
| +1 | K050118 | Ebi Trochanteric Nail System | Ebi, L.P. | 2005 | 3 |
| +2 | K120148 | Aos Solid Locking Lag Screw, Aos Telescoping Lag Screw | Advanced Orthopaedic Solutions, Inc. | 2012 | — |
| +2 | K083726 | Pedinail Intramedullary Nailing System | OrthoPediatrics Corp. | 2009 | 27 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (2)
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 |
|---|---|---|---|
| * | — | Synthes Titanium Unreamed Femoral Nail Named without a submission number | |
| * | — | Alta® Femoral Nail Named without a submission number |
What descends from it? (31)
See all 313 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K072161 (Biomet Manufacturing Corp, 2007) has gone furthest, with 22 descendants of its own.
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?
1) fresh fractures of the femur to include; non-comminuted midshaft fractures, subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures. 2) osteotomy and reconstructive procedures following tumor resection. 3) revision procedures where other treatments or devices have failed. 4) arthrodesis.
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/K983641 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983641: Holland Femoral Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983641
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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