510(k) · Cleared
Recalled · Class II · 2026ATL Anchors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Life Sciences · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Sep 2, 2020 as substantially equivalent to K193295 (Parcus Medical, LLC, 2020) and 1 other predicate after a 184-day review. Its family tree reaches back 6 generations to 1996. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 2, 2020
- Review
- 184 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 6 generations to K961555 (1996). 15 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 5 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 4 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 3 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 2 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- 1 generation backK093428 Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009
- This deviceK200503 ATL AnchorsInternational Life Sciences · 2020
- Descendant · cites it directly · 0 of its ownK260317 Artelon Convenience KitsInternational Life Sciences · 2026
- Descendant · cites it directly · 0 of its ownK253538 TeKBrace Knotless AnchorTheramicro · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −5 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −4 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −3 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −2 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| −1 | K093428 | Smith & Nephew Knotless Instability Anchor | Smith & Nephew Endoscopy, Inc. | 2009 | — |
| 0 (this device) | K200503 | ATL Anchors | International Life Sciences | 2020 | — |
| +1 | K260317 | Artelon Convenience Kits | International Life Sciences | 2026 | — |
| +1 | K253538 | TeKBrace Knotless Anchor | Theramicro | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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 |
|---|---|---|---|
| * | K193295 | Parcus Knotless PEEK and PEEK CF Push-In Suture AnchorSummary page 4…nt to the following devices: • Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors – K193295 • Smith and Nephew BIORAPTOR Knotless Suture Anc… | 2020 |
| * | K093428 | Smith & Nephew Knotless Instability AnchorSummary page 4…Suture Anchors – K193295 • Smith and Nephew BIORAPTOR Knotless Suture Anchor – K093428 Device Description: The ATL Anchors are press fit suture anchors designed to secure t… | 2009 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 6, 2026 | Class II | Z-1554-2026 | Process control | Augmentation devices failed bacterial endotoxin testing. |
| Feb 6, 2026 | Class II | Z-1556-2026 | Process control | Augmentation devices failed bacterial endotoxin testing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K260317 (International Life Sciences, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K193295.
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. 2020, this device’s year, is highlighted.
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 ATL Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications: * Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair. » Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra…
Read the full statement (113 words)
The ATL Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following
indications:
* Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
» Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Illiotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
* Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
* Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
» Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
* Hip: Acetabular labral repair.
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/K200503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200503: ATL Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200503
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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