510(k) · Cleared
Recalled · 2009Titanium Intramedullary Nails-Various Styles
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 Oct 21, 1998 after a 58-day review. The FDA summary names its predicate without a number. 121 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 21, 1998
- Review
- 58 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 4
- Predicates
- 0
121 later devices descend from it, 12 citing it directly.
- This deviceK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998
- Descendant · cites it directly · 41 of its ownK023115 Ace VersanailDePuy Orthopaedics, Inc. · 2002
- Descendant · cites it directly · 37 of its ownK063570 Biomet Tibial Locking Nail SystemBiomet Manufacturing Corp · 2007 · Recalled
- Descendant · cites it directly · 27 of its ownK021786 Titanium Ankle Arthrodesis NailBiomet, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 25 of its ownK101934 Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail…Medshape Solutions · 2011
- Descendant · 2 generations on · 24 of its ownK113828 Dynanail Ankle Arthrodesis NailMedShape, Inc. · 2012
Showing 5 of 121 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 121 · See all- K023115Ace VersanailDePuy Orthopaedics, Inc. · 2002 · cites it directly41descendants
- K063570Biomet Tibial Locking Nail SystemBiomet Manufacturing Corp · 2007 · cites it directly37descendants
- K021786Titanium Ankle Arthrodesis NailBiomet, Inc. · 2002 · cites it directly27descendants
- K101934Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222…Medshape Solutions · 2011 · 2 generations on25descendants
- K113828Dynanail Ankle Arthrodesis NailMedShape, Inc. · 2012 · 2 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982953 | Titanium Intramedullary Nails-Various Styles | Biomet, Inc. | 1998 | — |
| +1 | K023115 | Ace Versanail | DePuy Orthopaedics, Inc. | 2002 | — |
| +1 | K063570 | Biomet Tibial Locking Nail System | Biomet Manufacturing Corp | 2007 | 3 |
| +1 | K021786 | Titanium Ankle Arthrodesis Nail | Biomet, Inc. | 2002 | 1 |
| +2 | K101934 | Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models… | Medshape Solutions | 2011 | — |
| +2 | K113828 | Dynanail Ankle Arthrodesis Nail | MedShape, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 8 | 0 |
| 2018 | 6 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 11 | 0 |
| 2026 | 14 | 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? (5)
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 |
|---|---|---|---|
| * | — | Stainless steel intramedullary rods Named without a submission number | |
| * | — | Grosse Kempf System (Howmedica) Named without a submission number | |
| * | — | Intramedullary Nails (Zimmer) Named without a submission number | |
| * | — | Kirschner Intramedullary Nail System (now Biomet, Inc.) Named without a submission number | |
| * | — | OEC Kuntscher Cloverleaf Nail Systems (now Biomet, Inc.) Named without a submission number |
What descends from it? (121)
See all 12112 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023115 | Ace Versanail | 2002 | 41 |
| K063570 | Biomet Tibial Locking Nail System | 2007 | 37 |
| K021786 | Titanium Ankle Arthrodesis Nail | 2002 | 27 |
| K031438 | Acumed Small Bone Locking Rod System II | 2003 | 24 |
| K072161 | Biomet Femoral Locking Nail System | 2007 | 22 |
| K993956 | Titanium Pediatric Femoral Nail | 1999 | 14 |
| K012190 | Aos Modular Femoral Nail | 2001 | 10 |
| K013923 | Titanium Retrograde Femoral Nail - 13 MM Diameter | 2002 | 1 |
| K151456 | Small Bone Nail Implant | 2015 | 0 |
| K042409 | Modular Arthrodesis Nail | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 2, 2009 | Not classified | Z-2289-2009 | Nonconforming Material/Component | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. |
| Apr 2, 2009 | Not classified | Z-2288-2009 | Nonconforming Material/Component | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. |
| Mar 27, 2009 | Not classified | Z-2116-2009 | Nonconforming Material/Component | Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices. |
| Mar 16, 2005 | Not classified | Z-0918-05 | Other | The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023115 (DePuy Orthopaedics, Inc., 2002) has gone furthest, with 41 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?
Intramedullary rods made of titanium alloy are used for the same indications as stainless steel intramedullary rods that have been commercially available continually since the 1950s. These devices are to be implanted into the long bones for alignment, stabilization and fixation of fractures caused by trauma or disease, the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis. Intramedullary rods are used in the femur, tibia, fibula, humerus, radius, and ulna.
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/K982953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982953: Titanium Intramedullary Nails-Various Styles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982953
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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