510(k) · Cleared
ClearedKirschner Wires, Steinman Pins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evergreen Orthopedic Research Lab · HTY Pin, Fixation, Smooth
Cleared on Nov 9, 2010 as substantially equivalent to K960385 (Depuy, Inc., 1996) and 3 other predicates after a 95-day review. Its family tree reaches back 3 generations to 1996. 6 later devices descend from it.
- Decided
- Nov 9, 2010
- Review
- 95 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K960385 (1996). 6 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 2 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
- 1 generation backK030336 Kmedic External Fixation DevicesTeleflex Medical Group · 2003
- This deviceK102215 Kirschner Wires, Steinman PinsEvergreen Orthopedic Research Lab · 2010
- Descendant · cites it directly · 5 of its ownK112254 Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co. · 2011
- Descendant · 2 generations on · 2 of its ownK121004 Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co. · 2012
- Descendant · 3 generations on · 1 of its ownK162032 Arrowhead Mini-Rail FixatorArrowhead De, LLC · 2017
- Descendant · 2 generations on · 1 of its ownK150443 ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek · 2015
- Descendant · 4 generations on · 0 of its ownK252106 External Fixation Mini Rail SystemParagon 28, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co. · 2011 · cites it directly5descendants
- K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co. · 2012 · 2 generations on2descendants
- K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC · 2017 · 3 generations on1descendant
- K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek · 2015 · 2 generations on1descendant
- K252106External Fixation Mini Rail SystemParagon 28, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −2 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| −1 | K030336 | Kmedic External Fixation Devices | Teleflex Medical Group | 2003 | — |
| 0 (this device) | K102215 | Kirschner Wires, Steinman Pins | Evergreen Orthopedic Research Lab | 2010 | — |
| +1 | K112254 | Apex Kirschner Wires and Steinmann Pins | Apex Tools & Orthopedics Co. | 2011 | — |
| +2 | K121004 | Apex Kirschner Wires and Steinmann Pins | Apex Tools & Orthopedics Co. | 2012 | — |
| +3 | K162032 | Arrowhead Mini-Rail Fixator | Arrowhead De, LLC | 2017 | — |
| +2 | K150443 | ToeTac Hammertoe Fixation System | Restore Surgical, LLC Dba Instratek | 2015 | — |
| +4 | K252106 | External Fixation Mini Rail System | Paragon 28, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K960385 | Sterile Kirschner Wires and Steinmann PinsSummary page 1…11 SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Kirschner wires and Steinmann pins (K960385), Smith and Nephew (K994 143), Orthopro (K07055 5), and Telfiex… | 1996 |
| * | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular)…Summary page 1…TANTIALLY EQUIVALENT DEVICES: DePuy Kirschner wires and Steinmann pins (K960385), Smith and Nephew (K994 143), Orthopro (K07055 5), and Telfiex (K03… | 2000 |
| * | K070555 | Orthopro Steinman Pins and Kirschner WiresSummary page 1…hner wires and Steinmann pins (K960385), Smith and Nephew (K994 143), Orthopro (K07055 5), and Telfiex (K030336) DEVICE DESCRIPTION: The Operativ i… | 2007 |
| * | K030336 | Kmedic External Fixation DevicesSummary page 1…(K960385), Smith and Nephew (K994 143), Orthopro (K07055 5), and Telfiex (K030336) DEVICE DESCRIPTION: The Operativ internal/external fixation… | 2003 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112254 | Apex Kirschner Wires and Steinmann Pins | 2011 | 5 |
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?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K112254 (Apex Tools & Orthopedics Co., 2011) has gone furthest, with 5 descendants of its own.
- 16 other devices also cite its predicate K960385.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Operativ Kirschner wires and Steinmann pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102215: Kirschner Wires, Steinman Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102215
Report an extraction error
Are you the manufacturer?
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