510(k) · Cleared
ClearedOrthoguard AB Antimicrobial 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 Sep 23, 2002 as substantially equivalent to K012193 (Smith & Nephew, Inc., 2002) after a 42-day review. Its family tree reaches back 3 generations to 1985. 1 of the 11 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 23, 2002
- Review
- 42 days
- Class
- Class II
- Product code
- JEC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K850247 (1985). 10 ancestors in all. No later device cites it as a predicate yet. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK850247 Peritoneal Dialysis Coil CatheterSil-Med Corp. · 1985
- 2 generations backK961392 Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent IISil-Med Corp. · 1997
- 1 generation backK012193 Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc. · 2002
- This deviceK022676 Orthoguard AB Antimicrobial SleeveSmith & Nephew, Inc. · 2002
Class I recalls in this family
- K900263 Antimicrobial Multi-Lumen Central Venous Catheter2 generations back · 1990
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K850247 | Peritoneal Dialysis Coil Catheter | Sil-Med Corp. | 1985 | — |
| −2 | K961392 | Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II | Sil-Med Corp. | 1997 | — |
| −1 | K012193 | Amc Antimicrobial Pin/Wire Sleeve | Smith & Nephew, Inc. | 2002 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K012193 | Amc Antimicrobial Pin/Wire SleeveSummary page 1…ate Device / Substantial Equivalence Information The OrthoGuard AB Antimicrobial Wire Sleeve is similar to the OrthoGuard AB Antimicribial Pin Sleeves included in 510(k) K012193. The following properties of the wire sleeve are the same as for the pin sleeves currently offered: intended use, material and co… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 2 generations back · ◆ 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 5.0 years on median.
- 2 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K012193.
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 fixatioii of bones. The OrthoGuard AB Antimicrobial Sleeve is indicated to inhibit bacterial colonization on the pine/wire.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022676: Orthoguard AB Antimicrobial Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022676
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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