510(k) · Cleared
ClearedHarpoon Suture Anchors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Apr 16, 1998 after a 195-day review. The FDA summary names no predicate by number. 68 later devices descend from it.
- Decided
- Apr 16, 1998
- Review
- 195 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 0
68 later devices descend from it, 8 citing it directly.
- This deviceK973775 Harpoon Suture AnchorsBiomet, Inc. · 1998
- Descendant · cites it directly · 47 of its ownK012572 Soft Tissue Screw and WasherBiomet, Inc. · 2001
- Descendant · cites it directly · 30 of its ownK012872 Resorbable Screw AnchorArthrotek, Inc. · 2001
- Descendant · 2 generations on · 26 of its ownK041274 Resorbable Interference ScrewArthrotek, Inc. · 2004 · Recalled
- Descendant · cites it directly · 17 of its ownK012503 Metal Screw AnchorBiomet Manufacturing, Inc. · 2001
- Descendant · 2 generations on · 15 of its ownK032894 Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T…Linvatec Biomaterials, Inc. · 2004
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 68 · See all- K012572Soft Tissue Screw and WasherBiomet, Inc. · 2001 · cites it directly47descendants
- K012872Resorbable Screw AnchorArthrotek, Inc. · 2001 · cites it directly30descendants
- K041274Resorbable Interference ScrewArthrotek, Inc. · 2004 · 2 generations on26descendants
- K012503Metal Screw AnchorBiomet Manufacturing, Inc. · 2001 · cites it directly17descendants
- K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…Linvatec Biomaterials, Inc. · 2004 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973775 | Harpoon Suture Anchors | Biomet, Inc. | 1998 | — |
| +1 | K012572 | Soft Tissue Screw and Washer | Biomet, Inc. | 2001 | — |
| +1 | K012872 | Resorbable Screw Anchor | Arthrotek, Inc. | 2001 | — |
| +2 | K041274 | Resorbable Interference Screw | Arthrotek, Inc. | 2004 | 5 |
| +1 | K012503 | Metal Screw Anchor | Biomet Manufacturing, Inc. | 2001 | — |
| +2 | K032894 | Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T… | Linvatec Biomaterials, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2020 | 5 | 0 |
| 2022 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (68)
See all 688 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012572 | Soft Tissue Screw and Washer | 2001 | 47 |
| K012872 | Resorbable Screw Anchor | 2001 | 30 |
| K012503 | Metal Screw Anchor | 2001 | 17 |
| K071520 | Renovo Suture Anchors, Models 100-2001 Thru 100-5502X | 2007 | 7 |
| K042460 | TI - Screw Anchor SP | 2004 | 7 |
| K012469 | Resorbable NO Profile Screw and Washer | 2001 | 4 |
| K080447 | Surgicraft Screw Fixation System | 2008 | 0 |
| K071816 | Harpoon Suture Anchor | 2007 | 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?
- Of its descendants, K012572 (Biomet, Inc., 2001) has gone furthest, with 47 descendants of its own.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
1) Shoulder (Harpoon and Mini-Harpoon Suture Anchors) Bankart repair, SLAP lesion repair, -acromio-clavicular separation repair, rototar cuff repair, capsule repair and capsulolabral reconstruction, Biceps tendosis, deltoid reg 2) Wrist (Mini-Harpoon Suture Anchor only) Scapholunate ligament reconstruction 3) Elbow (Harpoon and Mini-Harpoon Suture Anchoré) Biceps tendon reattachment, Ulnar or radial collateral -‘ligament reconstruction . 4) Knee (Harpoon…
Read the full statement (98 words)
1) Shoulder (Harpoon and Mini-Harpoon Suture Anchors)
Bankart repair, SLAP lesion repair, -acromio-clavicular separation repair, rototar cuff repair, capsule repair and capsulolabral reconstruction, Biceps tendosis, deltoid reg
2) Wrist (Mini-Harpoon Suture Anchor only)
Scapholunate ligament reconstruction
3) Elbow (Harpoon and Mini-Harpoon Suture Anchoré)
Biceps tendon reattachment, Ulnar or radial collateral -‘ligament reconstruction .
4) Knee (Harpoon and Mini-Harpoon Suture -Anchors)
Extra-Capsular Repair:’ : '
Medial collateral ligament. repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar realignment and repair, patellar ligament and tendon repair, vastus medialis obliguus VMO) muscle advancement
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/K973775 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973775: Harpoon Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973775
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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