510(k) · Cleared
ClearedSuture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · JDR Staple, Fixation, Bone
Cleared on Jul 10, 1996 as substantially equivalent to K954443 (Poly-Medics,Inc., 1996) after a 77-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Jul 10, 1996
- Review
- 77 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954443 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK954443 Lactosorb Suture AnchorPoly-Medics,Inc. · 1996
- This deviceK961578 Suture AnchorUnited States Surgical, A Division of Tyco Healthc · 1996
- Descendant · cites it directly · 0 of its ownK973281 The Surgical Dynamics* S.D. Sorb* E-Z Tac*United States Surgical, A Division of Tyco Healthc · 1997
Most influential descendants
Showing 1 of 1 · See all- K973281The Surgical Dynamics* S.D. Sorb* E-Z Tac*United States Surgical, A Division of Tyco Healthc · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954443 | Lactosorb Suture Anchor | Poly-Medics,Inc. | 1996 | — |
| 0 (this device) | K961578 | Suture Anchor | United States Surgical, A Division of Tyco Healthc | 1996 | — |
| +1 | K973281 | The Surgical Dynamics* S.D. Sorb* E-Z Tac* | United States Surgical, A Division of Tyco Healthc | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (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 |
|---|---|---|---|
| * | K954443 | Lactosorb Suture AnchorSummary page 1…ization, packaging and method of use, the Surgical Dynamics™ Suture Anchor** is substantially equivalent to the currently marketed Poly-Medics Lactosorb® Suture Anchor (K954443) and other currently market devices by United States Surgical Corporation. Both the Surgical Dynamics™ Suture Anchor** and the P… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973281 | The Surgical Dynamics* S.D. Sorb* E-Z Tac* | 1997 | 0 |
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?
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?
Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are indicated for attachment of soft tissue to bone in shoulder, wrist and hand procedures
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961578 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961578: Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961578
Report an extraction error
Are you the manufacturer?
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