510(k) · Cleared
ClearedJavelot Ti Suture Anchor, Javelot Ti-D Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Endophix Co., Ltd. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Nov 2, 2023 as substantially equivalent to K100159 (Smith & Nephew Inc., Endoscopy Div., 2010) and 1 other predicate after a 57-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Nov 2, 2023
- Review
- 57 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K961555 (1996). 43 ancestors in all, the oldest K941364 (1994). No later device cites it as a predicate yet.
- Root · 10 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 6 generations between
- 3 generations backK100159 Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · Recalled
- 2 generations backK112526 Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012
- 1 generation backK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015 · Recalled
- This deviceK232725 Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd. · 2023
Show all 10 generations
- Root · 10 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 9 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 8 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 7 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 6 generations backK070908 Smith & Nephew Kinsa RC Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007
- 5 generations backK072785 Twinfix FT PKSmith & Nephew Inc., Endoscopy Division · 2007
- 4 generations backK093228 Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc. · 2009
- 3 generations backK100159 Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · Recalled
- 2 generations backK112526 Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012
- 1 generation backK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015 · Recalled
- This deviceK232725 Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −9 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −8 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −7 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −6 | K070908 | Smith & Nephew Kinsa RC Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | — |
| −5 | K072785 | Twinfix FT PK | Smith & Nephew Inc., Endoscopy Division | 2007 | — |
| −4 | K093228 | Smith & Nephew Twinfix Ultra PK Suture Anchor | Smith & Nephew, Inc. | 2009 | — |
| −3 | K100159 | Smith and Nephew Twinfix Ultra TI Suture Anchor | Smith & Nephew Inc., Endoscopy Div. | 2010 | 4 |
| −2 | K112526 | Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors | Smith & Nephew, Inc. | 2012 | — |
| −1 | K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01… | Smith & Nephew, Inc. | 2015 | 2 |
| 0 (this device) | K232725 | Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor | Suzhou Endophix Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 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 |
|---|---|---|---|
| * | K100159 | Smith and Nephew Twinfix Ultra TI Suture AnchorSummary page 6…nchor Common Name: Suture Anchor Classification: Class II, 21 CFR 888.3040 Product Code: MBI Premarket Notification: K100159 Manufacturer: Smith & Nephew, Inc., Endoscopy DIV. Reference device Trade Name: OBL 2.0 MM MI… | 2010 |
| * | K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Summary page 6…1 Common Name: suture anchor Classification: Class II, 21 CFR 888.3040 Product Code: MBI Premarket Notification: K152566 Manufacturer: Smith & Nephew, Inc., Endoscopy DIV. 1 === Page 7… | 2015 |
| † | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 10 of the 43 ancestors have a recall of any class.
- 3 other devices also cite its predicate K100159.
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. 2023, 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 Javelot Ti and Javelot Ti-D Suture Anchor are intended for connection and fixation of soft tissue to bone in the knee, hip, shoulder, elbow, ankle, foot, wrist and hand for the following indications: Shoulder: • Bankart lesion repair • SLAP lesion repair • Acromio-clavicular separation repair • Rotator cuff tear repair • Capsular shift or capsulolabral reconstruction • Biceps tenodesis • Deltoid repair Foot and Ankle: • Hallux valgus repair • Medial…
Read the full statement (158 words)
The Javelot Ti and Javelot Ti-D Suture Anchor are intended for connection and fixation of soft tissue to bone in the knee, hip, shoulder, elbow, ankle, foot, wrist and hand for the following indications:
Shoulder:
• Bankart lesion repair
• SLAP lesion repair
• Acromio-clavicular separation repair
• Rotator cuff tear repair
• Capsular shift or capsulolabral reconstruction
• Biceps tenodesis
• Deltoid repair
Foot and Ankle:
• Hallux valgus repair
• Medial or lateral instability repair/reconstruction
• Achilles tendon repair/reconstruction
• Midfoot reconstruction
• Metatarsal ligament/tendon repair/reconstruction
Elbow, Wrist and Hand:
• Ulnar or radial collateral ligament reconstruction
• Lateral epicondylitis repair
• Biceps tendon reattachment
• Scapholunate ligament reconstrontion (not for 4.5-6.5mm pro anchors)
Knee:
• Extra-capsular repair
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament
• Iliotibial band tenodesis
• Patellar realignment and tendon repair
- Vastus medialis obliquus advancement
Hip: (2.8-6.5mm anchors only)
• Capsular repair
• Acetabular labral repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232725: Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232725
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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