510(k) · Cleared
ClearedOsteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Femoral Nails with T2 Locking Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jun 15, 2001 as substantially equivalent to K992063 (Howmedica Osteonics Corp., 1999) and 3 other predicates after a 21-day review. Its family tree reaches back 1 generation to 1998. 12 later devices descend from it.
- Decided
- Jun 15, 2001
- Review
- 21 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K982601 (1998). 4 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK982601 Osteo IC Retrograde/Antegrade Femoral NailOsteonics Corp. · 1998
- This deviceK011622 Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade…Howmedica Osteonics Corp. · 2001
- Descendant · cites it directly · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
- Descendant · 2 generations on · 3 of its ownK161327 Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017
- Descendant · 3 generations on · 2 of its ownK181296 Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019
- Descendant · 2 generations on · 2 of its ownK141228 Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK230257 Arthrex Intramedullary NailsArthrex, Inc. · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · cites it directly10descendants
- K161327Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017 · 2 generations on3descendants
- K181296Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019 · 3 generations on2descendants
- K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014 · 2 generations on2descendants
- K230257Arthrex Intramedullary NailsArthrex, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982601 | Osteo IC Retrograde/Antegrade Femoral Nail | Osteonics Corp. | 1998 | — |
| 0 (this device) | K011622 | Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Femoral Nails… | Howmedica Osteonics Corp. | 2001 | — |
| +1 | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral… | I.T.S. GmbH | 2014 | — |
| +2 | K161327 | Syntec Humeral Nail System | Syntec Scientific Corporation | 2017 | — |
| +3 | K181296 | Syntec Femoral Nail System | Syntec Scientific Corporation | 2019 | — |
| +2 | K141228 | Aos 6.5MM Captured, Fully Threaded Cancellous Screw | Advanced Orthopaedic Solutions, Inc. | 2014 | — |
| +3 | K230257 | Arthrex Intramedullary Nails | Arthrex, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K992063 | Osteo IC Femoral and Tibial Nails in Titanium AlloySummary page 1…medullary Nails Classification Name and Reference: Intramedullary Fixation Rod, 21 CFR §888.3020 Predicate Device Identification The Osteo IC Femoral and Tibial Nails (K992063) and Osteo Retrograde/Antegrade (R/A) Femoral Nails (K982601) have been determined Substantially Equivalent when used with associ… | 1999 |
| * | K982601 | Osteo IC Retrograde/Antegrade Femoral NailSummary page 1…lary Fixation Rod, 21 CFR §888.3020 Predicate Device Identification The Osteo IC Femoral and Tibial Nails (K992063) and Osteo Retrograde/Antegrade (R/A) Femoral Nails (K982601) have been determined Substantially Equivalent when used with associated Osteo IC 5.0mm diameter Locking Screws. The T2 Femoral N… | 1998 |
| * | K010801 | T2 Femoral NailSummary page 1…grade (R/A) Femoral Nails (K982601) have been determined Substantially Equivalent when used with associated Osteo IC 5.0mm diameter Locking Screws. The T2 Femoral Nails (K010801) and T2 Tibial Nails (K003018) have also been determined Substantially Equivalent when used with associated T2 5.0mm diameter Loc… | 2001 |
| * | K003018 | Titan Tibial NailSummary page 1…2601) have been determined Substantially Equivalent when used with associated Osteo IC 5.0mm diameter Locking Screws. The T2 Femoral Nails (K010801) and T2 Tibial Nails (K003018) have also been determined Substantially Equivalent when used with associated T2 5.0mm diameter Locking Screws. This submission i… | 2000 |
What descends from it? (12)
See all 122 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?
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K132945 (I.T.S. GmbH, 2014) has gone furthest, with 10 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?
The T2 Locking Screws continue to be intended for single use only. They are intended for use with the predicate Osteo IC Femoral/Tibial Nail and Osteo R/A Nail Systems and, when used with these nail systems, are subject to their specific indications. Indications for the T2 Locking Screws when used with Osteo IC Femoral and Tibial Nails (K992063): Open and closed femoral and tibial shaft fractures Pseudoarthrosis and correction osteotomies Pathologic…
Read the full statement (159 words)
The T2 Locking Screws continue to be intended for single use only. They are intended for use with the predicate Osteo IC Femoral/Tibial Nail and Osteo R/A Nail Systems and, when used with these nail systems, are subject to their specific indications.
Indications for the T2 Locking Screws when used with Osteo IC Femoral and Tibial Nails (K992063):
Open and closed femoral and tibial shaft fractures
Pseudoarthrosis and correction osteotomies
Pathologic fractures and tumor resections
Change of procedure following external fixation
Indications for the T2 Locking Screws when used with Osteo R/A Femoral Nails (K982601):
The Osteo R/A Femoral Nail is indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:
Open and closed femoral fractures
Pseudoarthrosis and correction osteotomy
Pathologic fractures, impending pathologic fractures, and tumor resections
Supracondylar fractures, including those with intra-articular extension
Ipsilateral femur fractures
Fractures proximal to a total knee arthroplasty
Fractures distal to a hip implant
Nonunions and malunions
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/K011622 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011622: Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Femoral Nails with T2 Locking Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011622
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026