510(k) · Cleared
Recalled · 2011Anchorlok and Anchorlok RL Soft Tissue Anchor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jun 27, 1997 after an 81-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled 10 times.
- Decided
- Jun 27, 1997
- Review
- 81 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 10
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK971282 Anchorlok and Anchorlok RL Soft Tissue Anchor SystemWrightmedicaltechnologyinc · 1997
- Descendant · cites it directly · 2 of its ownK100579 G-Force TI Suture Anchor SystemWrightmedicaltechnologyinc · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK141011 G-Force Gen 2 Suture Anchor SystemWrightmedicaltechnologyinc · 2014
- Descendant · cites it directly · 1 of its ownK100630 G-Force Peek Suture Anchor SystemWrightmedicaltechnologyinc · 2010
- Descendant · 2 generations on · 0 of its ownK170265 GRAVITYTM PEEK-OPTIMA Suture AnchorWrightmedicaltechnologyinc · 2017
- Descendant · cites it directly · 0 of its ownK990095 Straight-in-Orthopedic Bone Screw Fixation SystemInfluence, Inc. · 1999
Most influential descendants
Showing 5 of 5 · See all- K100579G-Force TI Suture Anchor SystemWrightmedicaltechnologyinc · 2010 · cites it directly2descendants
- K141011G-Force Gen 2 Suture Anchor SystemWrightmedicaltechnologyinc · 2014 · 2 generations on1descendant
- K100630G-Force Peek Suture Anchor SystemWrightmedicaltechnologyinc · 2010 · cites it directly1descendant
- K170265GRAVITYTM PEEK-OPTIMA Suture AnchorWrightmedicaltechnologyinc · 2017 · 2 generations on0descendants
- K990095Straight-in-Orthopedic Bone Screw Fixation SystemInfluence, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971282 | Anchorlok and Anchorlok RL Soft Tissue Anchor System | Wrightmedicaltechnologyinc | 1997 | — |
| +1 | K100579 | G-Force TI Suture Anchor System | Wrightmedicaltechnologyinc | 2010 | 2 |
| +2 | K141011 | G-Force Gen 2 Suture Anchor System | Wrightmedicaltechnologyinc | 2014 | — |
| +1 | K100630 | G-Force Peek Suture Anchor System | Wrightmedicaltechnologyinc | 2010 | — |
| +2 | K170265 | GRAVITYTM PEEK-OPTIMA Suture Anchor | Wrightmedicaltechnologyinc | 2017 | — |
| +1 | K990095 | Straight-in-Orthopedic Bone Screw Fixation System | Influence, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2010 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | — | ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System Named without a submission number | |
| * | — | Mitek Anchor Named without a submission number |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 20, 2011 | Not classified | Z-0059-2012 | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. |
| Sep 20, 2011 | Not classified | Z-0064-2012 | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. |
| Sep 20, 2011 | Not classified | Z-0067-2012 | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. |
| Sep 20, 2011 | Not classified | Z-0065-2012 | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. |
| Sep 20, 2011 | Not classified | Z-0066-2012 | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. |
| Sep 20, 2011 | Not classified | Z-0058-2012 | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. |
| Sep 20, 2011 | Not classified | Z-0062-2012 | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. |
| Sep 20, 2011 | Not classified | Z-0063-2012 | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. |
| Sep 20, 2011 | Not classified | Z-0060-2012 | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. |
| Sep 20, 2011 | Not classified | Z-0061-2012 | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K100579 (Wrightmedicaltechnologyinc, 2010) has gone furthest, with 2 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?
The ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System is intended for use: . In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction; . In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation; . In…
Read the full statement (156 words)
The ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System is intended for use:
. In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
. In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation;
. In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
. Female urinary incontinence due to urethral hypermobility;
. In the repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;
. In the repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments;
. Lateral canthoplasty
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/K971282 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971282: Anchorlok and Anchorlok RL Soft Tissue Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971282
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