510(k) · Cleared
ClearedApollo Suture Anchor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valeris Medical · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 11, 2020 as substantially equivalent to K142230 (Valeris Medical, 2014) after a 162-day review. Its family tree reaches back 8 generations to 1996. 1 later device descends from it.
- Decided
- Mar 11, 2020
- Review
- 162 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K961555 (1996). 30 ancestors in all, the oldest K915424 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 7 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 6 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 5 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 4 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- 3 generations backK083635 Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
- 2 generations backK133036 Apollo Suture Anchor System and Titan ScrewsAmendia, Inc. · 2014 · Recalled
- 1 generation backK142230 Apollo Suture Anchor System and Titan ScrewsValeris Medical · 2014 · Recalled
- This deviceK192810 Apollo Suture Anchor SystemValeris Medical · 2020
- Descendant · cites it directly · 0 of its ownK230123 Apollo Knotless Suture AnchorMaruho Medical · 2023
Most influential descendants
Showing 1 of 1 · See all- K230123Apollo Knotless Suture AnchorMaruho Medical · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −7 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −6 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −5 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −4 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| −3 | K083635 | Smith & Nephew Biosure PK Interference Screw | Smith & Nephew Endoscopy, Inc. | 2009 | — |
| −2 | K133036 | Apollo Suture Anchor System and Titan Screws | Amendia, Inc. | 2014 | 1 |
| −1 | K142230 | Apollo Suture Anchor System and Titan Screws | Valeris Medical | 2014 | 1 |
| 0 (this device) | K192810 | Apollo Suture Anchor System | Valeris Medical | 2020 | — |
| +1 | K230123 | Apollo Knotless Suture Anchor | Maruho Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K142230 | Apollo Suture Anchor System and Titan ScrewsSummary page 5…Class II Regulation Number 21 CFR 888.3040 Product Code MBI Name of Predicate Device 510(k) # Manufacturer Apollo Suture Anchor System and K142230 Valeris Medical Titan Screws Description Apollo Family The Apollo Medial Suture Anchor, Medial… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230123 | Apollo Knotless Suture Anchor | 2023 | 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?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 9 of the 30 ancestors have a recall of any class.
- Of its descendants, K230123 (Maruho Medical, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K142230.
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?
Apolio Medial, Medial with Needles, and Apollo XT Suture Anchor: Shoulder Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromio-Clavicular Separation Repair Deltoid Repair Capisular Shift or Capsulolabral Reconstruction Foot/Ankle Lateral Stabilization Medial Stabilization Achilles Tendon Repair Knee Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Posterior Oblique Ligament Repair Iliotibial Band Tenodesis…
Read the full statement (150 words)
Apolio Medial, Medial with Needles, and Apollo XT Suture Anchor:
Shoulder
Rotator Cuff Repair
Bankart Repair
SLAP Lesion Repair
Biceps Tenodesis
Acromio-Clavicular Separation Repair
Deltoid Repair
Capisular Shift or Capsulolabral Reconstruction
Foot/Ankle
Lateral Stabilization
Medial Stabilization
Achilles Tendon Repair
Knee
Medial Collateral Ligament Repair
Lateral Collateral Ligament Repair
Posterior Oblique Ligament Repair
Iliotibial Band Tenodesis
Elbow
Biceps Tendon Reattachment
Ulnar or Radial Collateral Ligament Reconstruction
Hip
Capsular Repair
Acetabular Labral Repair
Apollo Knotless Anchor
Shoulder
Rotator Cuff Repair
Bankart Repair
SLAP Lesion Repair
Biceps Tenodesis
Acromio-Clavicular Separation Repair
Deltoid Repair
Capisular Shift or Capsulolabral Reconstruction
Wrist/Hand
Scapholunate Ligament Reconstruction
Ulnar/Radial Collateral Ligament Reconstruction
Foot/Ankle
Lateral Stabilization
Medial Stabilization
Achilles Tendon Repair/Reconstruction
Hallux Valgus Reconstruction
Mid- and Forefoot Reconstruction
Elbow
Biceps Tendon Reconstruction
Ulnar or Radial Collateral Ligament Reconstruction
Knee
Medial Collateral Ligament Repair
Lateral Collateral Ligament Repair
Posterior Oblique Ligament Repair
Joint Capsule Closure
Iliotibial Band Tenodesis
Patellar Ligament/Tendon 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/K192810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192810: Apollo Suture Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192810
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