510(k) · Cleared
ClearedKmedic External Fixation Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical Group · JDW Pin, Fixation, Threaded
Cleared on Mar 6, 2003 as substantially equivalent to K960385 (Depuy, Inc., 1996) and 1 other predicate after a 34-day review. Its family tree reaches back 2 generations to 1996. 16 later devices descend from it.
- Decided
- Mar 6, 2003
- Review
- 34 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K960385 (1996). 3 ancestors in all. 16 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 1 generation backK022599 Newdeal K WireNew Deal, S.A. · 2002
- This deviceK030336 Kmedic External Fixation DevicesTeleflex Medical Group · 2003
- Descendant · cites it directly · 7 of its ownK121008 Trilliant Surgical K-WiresTrilliant Surgical, Ltd. · 2012 · Recalled
- Descendant · cites it directly · 6 of its ownK102215 Kirschner Wires, Steinman PinsEvergreen Orthopedic Research Lab · 2010
- Descendant · 2 generations on · 5 of its ownK161449 HammerTech Fixation SystemFusion Orthopedics, LLC · 2016
- Descendant · 2 generations on · 5 of its ownK112254 Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co. · 2011
- Descendant · 3 generations on · 3 of its ownK201850 Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2020
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K121008Trilliant Surgical K-WiresTrilliant Surgical, Ltd. · 2012 · cites it directly7descendants
- K102215Kirschner Wires, Steinman PinsEvergreen Orthopedic Research Lab · 2010 · cites it directly6descendants
- K161449HammerTech Fixation SystemFusion Orthopedics, LLC · 2016 · 2 generations on5descendants
- K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co. · 2011 · 2 generations on5descendants
- K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2020 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −1 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| 0 (this device) | K030336 | Kmedic External Fixation Devices | Teleflex Medical Group | 2003 | — |
| +1 | K121008 | Trilliant Surgical K-Wires | Trilliant Surgical, Ltd. | 2012 | 1 |
| +1 | K102215 | Kirschner Wires, Steinman Pins | Evergreen Orthopedic Research Lab | 2010 | — |
| +2 | K161449 | HammerTech Fixation System | Fusion Orthopedics, LLC | 2016 | — |
| +2 | K112254 | Apex Kirschner Wires and Steinmann Pins | Apex Tools & Orthopedics Co. | 2011 | — |
| +3 | K201850 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 JDW? 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 JDW device
- #1 K260073 XT3 System; XT3 System, Mini; XT3 System…score 15.0 · 15 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 |
|---|---|---|---|
| * | K960385 | Sterile Kirschner Wires and Steinmann PinsSummary page 1…ires and Steinmann Pins - Preamendment (As referenced in DuPuy, Inc. Sterile Kirschner Wires and Steinmann Pins K960385) 0 NewDeal K-Wire - KO22599 Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or… | 1996 |
| * | K022599 | Newdeal K Wire | 2002 |
| * | — | George Tiemann & Co. Kirschner Wires, Steinmann Pins and Cerclage Wires - Preamendment Named without a submission number |
What descends from it? (16)
See all 164 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K121008 (Trilliant Surgical, Ltd., 2012) has gone furthest, with 7 descendants of its own.
- 16 other devices also cite its predicate K960385.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDW
Too few JDW 510(k)s in any year since 2007 to give a median.
Recalls per year · JDW
21in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDW
29in 2025
MAUDE reports naming product code JDW, 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 | 2 | — | 0 | 25 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 1 | — | 2 | 29 |
| 2010 | 2 | — | 2 | 29 |
| 2011 | 1 | — | 0 | 55 |
| 2012 | 1 | — | 52 | 75 |
| 2013 | 2 | — | 0 | 69 |
| 2014 | 2 | — | 0 | 27 |
| 2015 | 1 | — | 0 | 70 |
| 2016 | 0 | — | 0 | 46 |
| 2017 | 1 | — | 2 | 43 |
| 2018 | 1 | — | 21 | 94 |
| 2019 | 1 | — | 0 | 575 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 121 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 0 | — | 0 | 65 |
| 2025 | 2 | — | 0 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The KMedic External Fixation Devices are non-sterile, single-use, external fixation devices intended to be used for unilateral 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 external fixation modality.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030336 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030336: Kmedic External Fixation Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030336
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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