510(k) · Cleared
ClearedSuretac Iii, Models 7209900, 7209901
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · JDR Staple, Fixation, Bone
Cleared on Nov 7, 2002 as substantially equivalent to K911837 (Acufex Microsurgical, Inc., 1991) and 2 other predicates after a 27-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Nov 7, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K911837 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −1 | K020948 | Smith & Nephew Suretac - Expanded Indications II | Smith & Nephew, Inc. | 2002 | — |
| 0 (this device) | K023417 | Suretac Iii, Models 7209900, 7209901 | Smith & Nephew, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 JDR? 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 JDR device
- #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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 |
|---|---|---|---|
| * | K911837 | Suretac Polyglyconate Absorbable Fixation DeviceSummary page 1…issue Product Code MA1 (current classification) D. Predicate Devices SUKET,IC@ Pimuon Device (1<911837) SUREI'AC@Expanded Indcauon (IC931519) SURETACO Expanded Indi… | 1991 |
| * | K931519 | Acufex SuretacSummary page 1…ification) D. Predicate Devices SUKET,IC@ Pimuon Device (1<911837) SUREI'AC@Expanded Indcauon (IC931519) SURETACO Expanded Indication I1 (I<020948) E. Description of Device The SURET… | 1994 |
| * | K020948 | Smith & Nephew Suretac - Expanded Indications IISummary page 1…IC@ Pimuon Device (1<911837) SUREI'AC@Expanded Indcauon (IC931519) SURETACO Expanded Indication I1 (I<020948) E. Description of Device The SURETACO 111 is a bioabsorable fixator utilized for soft tissue to bone approximat… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 2 companies; a new generation was cleared every 10.9 years on median.
- None of the 3 ancestors has a recall.
- 6 other devices also cite its predicate K911837.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, 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 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
The SURETAC I11 is indicated for rotator cuff repair, repair of recurrent anterior shoulder dislocation and subluxaton, and repair of acute/primary anterior shoulder dislocation and subluxation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023417: Suretac Iii, Models 7209900, 7209901.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023417
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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