510(k) · Cleared
ClearedKmedic Internal/External Fixation Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · HTY Pin, Fixation, Smooth
Cleared on May 25, 2007 after an 87-day review. The FDA summary names its predicate without a number. 68 later devices descend from it.
- Decided
- May 25, 2007
- Review
- 87 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 0
68 later devices descend from it, 3 citing it directly.
- This deviceK070561 Kmedic Internal/External Fixation DevicesTeleflex Medical · 2007
- Descendant · cites it directly · 65 of its ownK100736 Kirschner and Guide WiresSmt Schilling Metalltechnik GmbH · 2010
- Descendant · 2 generations on · 24 of its ownK121277 Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire…Z-Medical GmbH & Co. KG · 2012
- Descendant · 3 generations on · 15 of its ownK131061 Restore Bunion Correction SystemNextremity Solutions · 2013
- Descendant · 2 generations on · 12 of its ownK131459 Aap K-Wire, Steinmann Pin, Cerclage WireAap Implantate AG · 2013
- Descendant · 2 generations on · 12 of its ownK120787 Merete Locking Bone Plate System IiiMerete Medical GmbH · 2012
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 68 · See all- K100736Kirschner and Guide WiresSmt Schilling Metalltechnik GmbH · 2010 · cites it directly65descendants
- K121277Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleZ-Medical GmbH & Co. KG · 2012 · 2 generations on24descendants
- K131061Restore Bunion Correction SystemNextremity Solutions · 2013 · 3 generations on15descendants
- K131459Aap K-Wire, Steinmann Pin, Cerclage WireAap Implantate AG · 2013 · 2 generations on12descendants
- K120787Merete Locking Bone Plate System IiiMerete Medical GmbH · 2012 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070561 | Kmedic Internal/External Fixation Devices | Teleflex Medical | 2007 | — |
| +1 | K100736 | Kirschner and Guide Wires | Smt Schilling Metalltechnik GmbH | 2010 | — |
| +2 | K121277 | Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple | Z-Medical GmbH & Co. KG | 2012 | — |
| +3 | K131061 | Restore Bunion Correction System | Nextremity Solutions | 2013 | — |
| +2 | K131459 | Aap K-Wire, Steinmann Pin, Cerclage Wire | Aap Implantate AG | 2013 | — |
| +2 | K120787 | Merete Locking Bone Plate System Iii | Merete Medical GmbH | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 9 | 0 |
| 2024 | 8 | 0 |
| 2025 | 3 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 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 |
|---|---|---|---|
| * | — | Zimmer K-Wires Named without a submission number | |
| * | — | Zimmer Steinmann Pins Named without a submission number | |
| * | — | Zimmer Schanz Screws Named without a submission number |
What descends from it? (68)
See all 683 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, K100736 (Smt Schilling Metalltechnik GmbH, 2010) has gone furthest, with 65 descendants of its own.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The KMedic® Internal/External Fixation Devices are non-sterile, single-use; internal/external fixation devices intended to be used for unilateral internal/external fixation in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the internal/external fixation modality.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070561: Kmedic Internal/External Fixation Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070561
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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