510(k) · Cleared
Recalled · Class II · 2018Apollo Suture Anchor System and Titan Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amendia, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 6, 2014 as substantially equivalent to K083635 (Smith & Nephew Endoscopy, Inc., 2009) and 4 other predicates after a 161-day review. Its family tree reaches back 6 generations to 1996. 7 later devices descend from it. It has been recalled once.
- Decided
- Mar 6, 2014
- Review
- 161 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 6 generations to K961555 (1996). 28 ancestors in all, the oldest K915424 (1993). 7 later devices descend from it, 3 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 backK083635 Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
- This deviceK133036 Apollo Suture Anchor System and Titan ScrewsAmendia, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK142230 Apollo Suture Anchor System and Titan ScrewsValeris Medical · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK192810 Apollo Suture Anchor SystemValeris Medical · 2020
- Descendant · 2 generations on · 1 of its ownK152255 BoneCam Suture AnchorsValeris Medical · 2015
- Descendant · cites it directly · 0 of its ownK230123 Apollo Knotless Suture AnchorMaruho Medical · 2023
- Descendant · 2 generations on · 0 of its ownK230655 PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewSignature Orthopaedics Pty, Ltd. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical · 2014 · cites it directly5descendants
- K192810Apollo Suture Anchor SystemValeris Medical · 2020 · 2 generations on1descendant
- K152255BoneCam Suture AnchorsValeris Medical · 2015 · 2 generations on1descendant
- K230123Apollo Knotless Suture AnchorMaruho Medical · 2023 · cites it directly0descendants
- K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewSignature Orthopaedics Pty, Ltd. · 2023 · 2 generations on0descendants
View 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 | K083635 | Smith & Nephew Biosure PK Interference Screw | Smith & Nephew Endoscopy, Inc. | 2009 | — |
| 0 (this device) | K133036 | Apollo Suture Anchor System and Titan Screws | Amendia, Inc. | 2014 | — |
| +1 | K142230 | Apollo Suture Anchor System and Titan Screws | Valeris Medical | 2014 | 1 |
| +2 | K192810 | Apollo Suture Anchor System | Valeris Medical | 2020 | — |
| +2 | K152255 | BoneCam Suture Anchors | Valeris Medical | 2015 | — |
| +1 | K230123 | Apollo Knotless Suture Anchor | Maruho Medical | 2023 | — |
| +2 | K230655 | PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw | Signature Orthopaedics Pty, Ltd. | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2020 | 2 | 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 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? (5)
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 |
|---|---|---|---|
| * | K083635 | Smith & Nephew Biosure PK Interference ScrewSummary page 2…K133036 Predicate Device The Apollo Suture Anchor System and Titan Screws are substantially equivalent to Smith and Nephew Biosure PK Interference Screw (K083635), the DePuy Mitek Healix PEEK Anchor (K(120449), the Biomet PEEK Allthread Knotless Suture Anchor and Hitch PEEK Anchor (K(071569… | 2009 |
| * | K120449 | Healix Advance Peek AnchorSummary page 2…llo Suture Anchor System and Titan Screws are substantially equivalent to Smith and Nephew Biosure PK Interference Screw (K083635), the DePuy Mitek Healix PEEK Anchor (K(120449), the Biomet PEEK Allthread Knotless Suture Anchor and Hitch PEEK Anchor (K(071569 and K(060693), and the Arthrex Tenodesis Screw… | 2012 |
| * | K071569 | Allthread Peek Anchor with Tantalum MarkerSummary page 2…Nephew Biosure PK Interference Screw (K083635), the DePuy Mitek Healix PEEK Anchor (K(120449), the Biomet PEEK Allthread Knotless Suture Anchor and Hitch PEEK Anchor (K(071569 and K(060693), and the Arthrex Tenodesis Screw (K(041356). Intended Use / Indications for Use The Apollo Suture Anchors and T… | 2007 |
| * | K060693 | Microstrike and Allthread Peek Suture AnchorSummary page 2…re PK Interference Screw (K083635), the DePuy Mitek Healix PEEK Anchor (K(120449), the Biomet PEEK Allthread Knotless Suture Anchor and Hitch PEEK Anchor (K(071569 and K(060693), and the Arthrex Tenodesis Screw (K(041356). Intended Use / Indications for Use The Apollo Suture Anchors and Titan Screws a… | 2006 |
| * | K041356 | Arthrex Tenodesis Screw FamilySummary page 2…y Mitek Healix PEEK Anchor (K(120449), the Biomet PEEK Allthread Knotless Suture Anchor and Hitch PEEK Anchor (K(071569 and K(060693), and the Arthrex Tenodesis Screw (K(041356). Intended Use / Indications for Use The Apollo Suture Anchors and Titan Screws are indicated for use in fixation of ligament… | 2004 |
What descends from it? (7)
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 |
|---|---|---|---|---|
| Jul 16, 2018 | Class II | Z-0104-2019 | Process control | The product was mislabeled as containing the incorrect type of suture. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 7 of the 28 ancestors have a recall of any class.
- Of its descendants, K142230 (Valeris Medical, 2014) has gone furthest, with 5 descendants of its own.
- 10 other devices also cite its predicate K083635.
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. 2014, 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 Apollo Suture Anchors and Titan Screws are indicated for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The screws are intended for use in the following procedures: Indications - Apollo Medial Suture Anchor The Apollo Medial Suture Anchor is intended for: Shoulder Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromioclavicular Separation…
Read the full statement (626 words)
The Apollo Suture Anchors and Titan Screws are indicated for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The screws are intended for use in the following procedures:
Indications - Apollo Medial Suture Anchor
The Apollo Medial Suture Anchor is intended for:
Shoulder
Rotator Cuff Repair
Bankart Repair
SLAP Lesion Repair
Biceps Tenodesis
Acromioclavicular Separation Repair
Deltoid Repair
Capsular 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
Indications - Apollo Lateral Anchor
The Apollo Lateral Anchor is indicated for:
Shoulder
Rotator Cuff Repair
Bankart Repair
SLAP Lesion Repair
Biceps Tenodesis
Acromioclavicular Separation Repair
Deltoid Repair
Capsular 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
Midfoot Forefoot Reconstruction
Elbow
Biceps Tendon Reconstruction
Ulnar or Radial Collateral Ligament Reconstruction
Lateral Epicondylitis Repair (PEEK Anchor Only)
Knee
Medial Collateral Ligament Repair
Lateral Collateral Ligament Repair
Posterior Oblique Ligament Repair
Joint Capsule Closure
Iliotibial Band Tenodesis
Patellar Ligament/Tendon Repair
Indications - Apollo Labral Suture Tac
Shoulder
Rotator Cuff Repair
Bankart Repair
SLAP Lesion Repair
Biceps Tenodesis
Acromioclavicular Separation Repair
Deltoid Repair
Capsular Shift or Capsulolabral Reconstruction
Wrist
Scapholunate Ligament Reconstruction
Elbow
Biceps Tendon Reattachment
Ulnar or Radial Collateral Ligament Reconstruction
Hip
Capsular Repair
Acetabular Labral Repair
Knee
Extracapsular Repair
Medial Collateral Ligament Repair
Lateral Collateral Ligament Repair
Posterior Oblique Ligament Repair
Joint Capsule Closure
Iliotibial Band Tenodesis Reconstruction
Patellar Ligament/Tendon Repair
Vastus Medialis Obliquus Muscle Advancement
Indications - Interference Screws
The Titan Interference Screws are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9 mm or less and a length of 23 mm or less are also intended for use in the following procedures:
Knee
ACL repairs
PCL repairs
Extracapsular repairs
Medial collateral ligament
Lateral collateral ligament
Posterior oblique ligament
Patellar realignment and tendon repairs
Vastus medialis obliquus advancement
Iliotibial band tenodesis
Shoulder
Capsular stabilization
Bankart repair
Anterior shoulder instability
SLAP lesion repairs
Capsular shift of capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodesis
Foot and Ankle
Hallux valgus repairs
Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Bunionectomy
Flexor Hallucis Longus
Tendon transfers
Elbow, Wrist, and Hand
Biceps tendon reattachment
Ulnar or radial collateral ligament reconstructions
Lateral epicondylitis repair
Scapholunate ligament reconstruction
Tendon transfers
Indications - Tenodesis Screws
The Titan Tenodesis Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. See below for specific indications.
The Tenodesis Screws are intended to provide soft tissue reattachment (i.e. fixation of ligament and tendon graft tissue). See below for specific indications.
Shoulder
Capsular stabilization
Bankart repair
Anterior shoulder instability
SLAP lesion repairs
Capsular shift of capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodesis
Foot and Ankle
Hallux valgus reconstruction
Medial stabilization
Lateral stabilization
Achilles Tendon Repair
Midfoot reconstructions
Metatarsal ligament repair
Bunionectomy
Flexor Hallucis Longus for Achilles Tendon reconstruction
Tendon transfers in the foot and ankle
Knee
Medial Collateral Ligament Repair
Lateral Collateral Ligament Repair
Patellar Tendon Repair
Posterior Oblique Ligament Repair
Iliotibial Band Tenodesis
Posterior Cruciate Ligament Repair
Elbow
Biceps tendon reattachment
Ulnar or radial collateral ligament reconstruction
Wrist and Hand
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
Lateral Epicondylitis repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133036 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133036: Apollo Suture Anchor System and Titan Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133036
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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