510(k) · Cleared
ClearedGii Quickanchor Plus with Orthocord Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · JDR Staple, Fixation, Bone
Cleared on Aug 5, 2005 as substantially equivalent to K041115 (Depuy Mitek, A Johnson & Johnson Company, 2004) after a 14-day review. Its family tree reaches back 2 generations to 1992. 3 later devices descend from it.
- Decided
- Aug 5, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915889 (1992). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK915889 Mitek Bone Anchor, ModificationMitek Surgical Products, Inc. · 1992
- 1 generation backK041115 Gii Quickanchor PlusDepuy Mitek, A Johnson & Johnson Company · 2004 · Recalled
- This deviceK051989 Gii Quickanchor Plus with Orthocord SutureDepuy Mitek, A Johnson & Johnson Company · 2005
- Descendant · cites it directly · 1 of its ownK111631 Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture…Depuy Mitek, A Johnson & Johnson Company · 2011
- Descendant · 2 generations on · 0 of its ownK112417 VariousDepuy Mitek, A Johnson & Johnson Company · 2012
- Descendant · cites it directly · 0 of its ownK110800 Meta-Lock Suture Anchor SystemTarsus Medical, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See all- K111631Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff…Depuy Mitek, A Johnson & Johnson Company · 2011 · cites it directly1descendant
- K112417VariousDepuy Mitek, A Johnson & Johnson Company · 2012 · 2 generations on0descendants
- K110800Meta-Lock Suture Anchor SystemTarsus Medical, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915889 | Mitek Bone Anchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| −1 | K041115 | Gii Quickanchor Plus | Depuy Mitek, A Johnson & Johnson Company | 2004 | 1 |
| 0 (this device) | K051989 | Gii Quickanchor Plus with Orthocord Suture | Depuy Mitek, A Johnson & Johnson Company | 2005 | — |
| +1 | K111631 | Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor… | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| +2 | K112417 | Various | Depuy Mitek, A Johnson & Johnson Company | 2012 | — |
| +1 | K110800 | Meta-Lock Suture Anchor System | Tarsus Medical, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K041115 | Gii Quickanchor PlusSummary page 1…GII Quickanchor Plus (with ORTHOCORD) is substantially equivalent to: GiI Quickanchor Plus, K041 115, manufactured by DePuy Mitek. Device Classification Bone anchors/screws are classified by the FDA as Class II Medic… | 2004 |
What descends from it? (3)
2 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)
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 13 years and passes through 2 companies; a new generation was cleared every 11.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K111631 (Depuy Mitek, A Johnson & Johnson Company, 2011) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K041115.
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 Mitek GIl Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below. Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair. Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction. Foot: Hallux valgus reconstruction. Wrist…
Read the full statement (108 words)
The Mitek GIl Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below.
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair.
Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction.
Foot: Hallux valgus reconstruction.
Wrist: Scapholunate ligament.
Hand: Ulnar or lateral collateral ligament reconstruction.
Elbow: Tennis elbow repair, biceps tendon reattachment.
Knee: Extra capsular repairs; Reattachment of. medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051989 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051989: Gii Quickanchor Plus with Orthocord Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051989
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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