510(k) · Cleared
ClearedCitregen Tendon Interference Screw and Citrelock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acuitive Technologies · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Oct 7, 2020 as substantially equivalent to K051726 (Arthrex, Inc., 2005) after a 202-day review. Its family tree reaches back 1 generation to 2005. 4 later devices descend from it.
- Decided
- Oct 7, 2020
- Review
- 202 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051726 (2005). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK051726 Arthrex Tenodesis FamilyArthrex, Inc. · 2005
- This deviceK200725 Citregen Tendon Interference Screw and CitrelockAcuitive Technologies · 2020
- Descendant · cites it directly · 3 of its ownK210239 CITRESPLINE and CITRELOCK ACL ImplantsAcuitive Technologies, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK220833 Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline…Acuitive Technologies, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK232592 Citrelock® DuoAcuitive Technologies, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK221468 Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon…Acuitive Technologies, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K210239CITRESPLINE and CITRELOCK ACL ImplantsAcuitive Technologies, Inc. · 2021 · cites it directly3descendants
- K220833Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock…Acuitive Technologies, Inc. · 2022 · cites it directly1descendant
- K232592Citrelock® DuoAcuitive Technologies, Inc. · 2023 · cites it directly0descendants
- K221468Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device…Acuitive Technologies, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051726 | Arthrex Tenodesis Family | Arthrex, Inc. | 2005 | — |
| 0 (this device) | K200725 | Citregen Tendon Interference Screw and Citrelock | Acuitive Technologies | 2020 | — |
| +1 | K210239 | CITRESPLINE and CITRELOCK ACL Implants | Acuitive Technologies, Inc. | 2021 | — |
| +1 | K220833 | Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and… | Acuitive Technologies, Inc. | 2022 | — |
| +1 | K232592 | Citrelock® Duo | Acuitive Technologies, Inc. | 2023 | — |
| +1 | K221468 | Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device… | Acuitive Technologies, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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? (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 |
|---|---|---|---|
| * | K051726 | Arthrex Tenodesis FamilySummary page 4…acturer Address: 50 Commerce Drive, Allendale, NJ 07401, USA Contact Name: Jaclyn Docs C. PRIMARY PREDICATE DEVICE K051726 Arthrex Tenodesis Family October 6, 2020 Page 1 of 4… | 2005 |
What descends from it? (4)
4 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?
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Citregen Tendon Interference Screw (TIS) and Citrelock are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically: Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle…
Read the full statement (148 words)
The Citregen Tendon Interference Screw (TIS) and Citrelock are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically:
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200725 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200725: Citregen Tendon Interference Screw and Citrelock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200725
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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