510(k) · Cleared
ClearedAmc Antimicrobial Pin/Wire Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · JEC Component, Traction, Invasive
Cleared on Jul 11, 2002 as substantially equivalent to K994143 (Smith & Nephew, Inc., 2000) and 5 other predicates after a 364-day review. Its family tree reaches back 2 generations to 1985. 1 of the 12 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Jul 11, 2002
- Review
- 364 days
- Class
- Class II
- Product code
- JEC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K850247 (1985). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK850247 Peritoneal Dialysis Coil CatheterSil-Med Corp. · 1985
- 1 generation backK961392 Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent IISil-Med Corp. · 1997
- This deviceK012193 Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK022688 Versabond AB Bone CementSmith & Nephew, Inc. · 2004 · Recalled
- Descendant · cites it directly · 0 of its ownK022676 Orthoguard AB Antimicrobial SleeveSmith & Nephew, Inc. · 2002
Class I recalls in this family
- K900263 Antimicrobial Multi-Lumen Central Venous Catheterdirect predicate · 1990
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 |
|---|---|---|---|---|---|
| −2 | K850247 | Peritoneal Dialysis Coil Catheter | Sil-Med Corp. | 1985 | — |
| −1 | K961392 | Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II | Sil-Med Corp. | 1997 | — |
| 0 (this device) | K012193 | Amc Antimicrobial Pin/Wire Sleeve | Smith & Nephew, Inc. | 2002 | — |
| +1 | K022688 | Versabond AB Bone Cement | Smith & Nephew, Inc. | 2004 | 1 |
| +1 | K022676 | Orthoguard AB Antimicrobial Sleeve | Smith & Nephew, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 1 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 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.
1 device in this family has a Class I recall. 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 JEC device
- #1 K193256 Anjon Bremer Halo Systemscore 3.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular)…Summary page 1…ivalence Information The OrthoGuard AB Antimicrobial Sleeve is similar to the following devices: Smith & Nephew External Fixation System (K994143) EBI X Dyna Fix System SC Bone Screws (K961433) Antimicrobial Multi-Lumen Central Ven… | 2000 |
| * | K961433 | Ebi X Fix Dynafix System/Ebi DFS Distal Radius Fixator SC Bone ScrewsSummary page 1…is similar to the following devices: Smith & Nephew External Fixation System (K994143) EBI X Dyna Fix System SC Bone Screws (K961433) Antimicrobial Multi-Lumen Central Venous Catheter (K900263) Niagara Dialysis Cathete… | 1996 |
| * | K900263 | Antimicrobial Multi-Lumen Central Venous CatheterSummary page 1…l Fixation System (K994143) EBI X Dyna Fix System SC Bone Screws (K961433) Antimicrobial Multi-Lumen Central Venous Catheter (K900263) Niagara Dialysis Catheter (K965 178) Bio-Guard AB Coated Catheter (K863354)… | 1990 |
| * | K965178 | Niagara Dual Lumen CatheterSummary page 1…na Fix System SC Bone Screws (K961433) Antimicrobial Multi-Lumen Central Venous Catheter (K900263) Niagara Dialysis Catheter (K965 178) Bio-Guard AB Coated Catheter (K863354) Antimicrobial Peritoneal Dialysis Coil Cathet… | 1997 |
| * | K863354 | Bio-Guard AB Coated CatheterSummary page 1…ntimicrobial Multi-Lumen Central Venous Catheter (K900263) Niagara Dialysis Catheter (K965 178) Bio-Guard AB Coated Catheter (K863354) Antimicrobial Peritoneal Dialysis Coil Catheter (K96 1392) All of the devices listed above are ei… | 1986 |
| * | K961392 | Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent IISummary page 1…Niagara Dialysis Catheter (K965 178) Bio-Guard AB Coated Catheter (K863354) Antimicrobial Peritoneal Dialysis Coil Catheter (K96 1392) All of the devices listed above are either used for orthopaedic use and/or contain antimicrobial agents, and ar… | 1997 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · Direct predicate · ◆ in the 1990 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 12.4 years on median.
- 2 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K022688 (Smith & Nephew, Inc., 2004) has gone furthest, with 0 descendants of its own.
- 18 other devices also cite its predicate K994143.
How does its category compare?
All JEC devicesJEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEC
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JEC
Too few JEC 510(k)s in any year since 2007 to give a median.
Recalls per year · JEC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEC
2in 2025
MAUDE reports naming product code JEC, 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 | 1 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 9 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 1 | 8 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 2 | — | 1 | 2 |
| 2019 | 1 | — | 1 | 3 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OrthoGuard AB Antimicrobial Sleeve is intended to be used as an accessory surrounding
orthopaedic pins and wires during external fixation of bones. The OrthoGuard AI3
Antimicrobial Sleeve is indicated to inhibit bacterial colonization on the pidwire.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K012193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012193: Amc Antimicrobial Pin/Wire Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012193
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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