510(k) · Cleared
ClearedK-FIX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Deal, S.A. · HTY Pin, Fixation, Smooth
Cleared on Nov 1, 2002 as substantially equivalent to K914812 (Westcon Orthopedics, Inc., 1992) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1983. 2 later devices descend from it.
- Decided
- Nov 1, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K831072 (1983). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK831072 Jurgan Pin BallJurgan Development & Mfg., Ltd. · 1983
- This deviceK022597 K-FIXNew Deal, S.A. · 2002
- Descendant · cites it directly · 1 of its ownK203698 CoLink Sfx Implant SystemIn2bones USA, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK231905 Electro-Spec Steri-CapsElectro-Spec, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831072 | Jurgan Pin Ball | Jurgan Development & Mfg., Ltd. | 1983 | — |
| 0 (this device) | K022597 | K-FIX | New Deal, S.A. | 2002 | — |
| +1 | K203698 | CoLink Sfx Implant System | In2bones USA, LLC | 2021 | — |
| +2 | K231905 | Electro-Spec Steri-Caps | Electro-Spec, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K914812 | K-Cap-E, SterileSummary page 2…. PREDICATE DEVICE: The K-FIX@ is substantially equivalent to K-CAP-ES external protective caps from Westcon orthopedics (K9148 12), the Jurgan pin Ball8 (K83 1072) from Jurgan Development and Mfg. 0. COMPARISON OF TECHNOLOGICAL… | 1992 |
| * | K831072 | Jurgan Pin BallSummary page 2…is substantially equivalent to K-CAP-ES external protective caps from Westcon orthopedics (K9148 12), the Jurgan pin Ball8 (K83 1072) from Jurgan Development and Mfg. 0. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: K FIX@(Newde… | 1983 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203698 | CoLink Sfx Implant System | 2021 | 1 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K203698 (In2bones USA, LLC, 2021) has gone furthest, with 1 descendant 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.
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 wire protecting caps K-FIX03 are indicated for use in the protection of protruding ends of wires.
Examples of protruding wires include:
-Osteotomies, arthrodesis or fractures management in the foot or hand.
-Fixation of small bone fragments, in long bones or small bones fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022597 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022597: K-FIX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022597
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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