510(k) Report

510(k) · Cleared

Cleared

Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)

K231002510(k) TraditionalCleared Jun 7, 202361-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Suzhou Endophix Co., Ltd. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Jun 7, 2023 as substantially equivalent to K093228 (Smith & Nephew, Inc., 2009) and 7 other predicates after a 61-day review. Its family tree reaches back 12 generations to 1979.

Decided
Jun 7, 2023
Review
61 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
8

Its longest line of descent runs back 12 generations to K792022 (1979). 114 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2014: 1 other ancestor2012: 1 other ancestor2011: 4 other ancestors2010: 1 other ancestor2009: 4 other ancestors2006: 7 other ancestors2020: 1 other ancestor2008: 2 other ancestors2007: 7 other ancestors2005: 5 other ancestors2019: 1 other ancestor2003: 3 other ancestors2001: 10 other ancestors2000: 7 other ancestors1998: 5 other ancestors1997: 6 other ancestors2017: 1 other ancestor2016: 1 other ancestor1996: 9 other ancestors2004: 3 other ancestors2002: 3 other ancestors1999: 8 other ancestors1982: 1 other ancestor1993: 2 other ancestors1992: 1 other ancestor1995: 4 other ancestors1994: 2 other ancestors1990: 2 other ancestorsK792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalledK974876 · Bionx Distal Radius Screw · Bionx Implants, Inc. · 1998K992947 · Cannulated Smartscrew Models 224540C, 224570C · Bionx Implants, Ltd. · 1999K012001 · Smartscrew · Bionx Implants, Ltd. · 2001K030900 · Inion Otps Biodegradable Fixaton System · Inion, Ltd. · 2003K043248 · Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS · Arthrex, Inc. · 2005K083070 · Toggleloc System · Biomet Sports Medicine · 2008 · recalledK123341 · Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex Proximal Biceps Button · Arthrex, Inc. · 2012K150768 · JuggerKnot Soft Anchors · Biomet Manufacturing Corp · 2015×2: 2 generations cleared close together, K180768 (2018), K191226 (2019) K203495 · Arthrex SwiveLock Anchor · Arthrex, Inc. · 2021 · recalled19801990200020102020
Other ancestors, by generation 1 generation back: 7 other ancestors2 generations back: 14 other ancestors3 generations back: 11 other ancestors4 generations back: 3 other ancestors5 generations back: 2 other ancestors6 generations back: 8 other ancestors7 generations back: 15 other ancestors8 generations back: 22 other ancestors9 generations back: 12 other ancestors10 generations back: 5 other ancestors11 generations back: 3 other ancestors K203495 · Arthrex SwiveLock Anchor · Arthrex, Inc. · 2021 · recalledK191226 · Arthrex SwiveLock Suture Anchor · Arthrex, Inc. · 2019K180768 · Arthrex SwiveLock Anchors · Arthrex, Inc. · 2018K150768 · JuggerKnot Soft Anchors · Biomet Manufacturing Corp · 2015K123341 · Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex Proximal Biceps Button · Arthrex, Inc. · 2012K083070 · Toggleloc System · Biomet Sports Medicine · 2008 · recalledK043248 · Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS · Arthrex, Inc. · 2005K030900 · Inion Otps Biodegradable Fixaton System · Inion, Ltd. · 2003K012001 · Smartscrew · Bionx Implants, Ltd. · 2001K992947 · Cannulated Smartscrew Models 224540C, 224570C · Bionx Implants, Ltd. · 1999K974876 · Bionx Distal Radius Screw · Bionx Implants, Inc. · 1998K792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalled−10−50
  1. Root · 12 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
  2. 8 generations between
  3. 3 generations backK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
  4. 2 generations backK191226 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019
  5. 1 generation backK203495 Arthrex SwiveLock AnchorArthrex, Inc. · 2021 · Recalled
  6. This deviceK231002 Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless)…Suzhou Endophix Co., Ltd. · 2023
Show all 12 generations
  1. Root · 12 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
  2. 11 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
  3. 10 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
  4. 9 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
  5. 8 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
  6. 7 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
  7. 6 generations backK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
  8. 5 generations backK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012
  9. 4 generations backK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
  10. 3 generations backK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
  11. 2 generations backK191226 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019
  12. 1 generation backK203495 Arthrex SwiveLock AnchorArthrex, Inc. · 2021 · Recalled
  13. This deviceK231002 Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless)…Suzhou Endophix Co., Ltd. · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K792022Herbert Bone ScrewZimmer, Inc.19796
−11K974876Bionx Distal Radius ScrewBionx Implants, Inc.1998—
−10K992947Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd.1999—
−9K012001SmartscrewBionx Implants, Ltd.2001—
−8K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd.2003—
−7K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…Arthrex, Inc.2005—
−6K083070Toggleloc SystemBiomet Sports Medicine20086
−5K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button…Arthrex, Inc.2012—
−4K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp2015—
−3K180768Arthrex SwiveLock AnchorsArthrex, Inc.2018—
−2K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.2019—
−1K203495Arthrex SwiveLock AnchorArthrex, Inc.20211
0 (this device)K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot…Suzhou Endophix Co., Ltd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
199020
199210
199320
199420
199540
199690
199760
199850
199980
200070
2001100
200230
200330
200430
200550
200670
200770
200820
200940
201010
201140
201210
201410
201610
201710
201910
202010
FIG. 1 — Lineage of K231002, 1979–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K093228Smith & Nephew Twinfix Ultra PK Suture Anchor
Summary page 13
…nchor Common Name: suture anchor Classification: Class II, 21 CFR 888.3040 Product Code: MBI Premarket Notification: K093228 Manufacturer: Smith & Nephew, Inc., Endoscopy Division Trade Name: Arthrex Swivelock Anchors C…
Smith & Nephew, Inc.2009—
*K101823Arthrex Swivelock Anchors
Summary page 13
…suture anchor Classification: Class II, 21 CFR 888.3040, 21 CFR 888.3030 Product Code: MAI, HWC Premarket Notification: K101823 1…
Arthrex, Inc.20116
*K203495Arthrex SwiveLock Anchor
Summary page 14
…Common Name: suture anchor Classification: Class II, 21 CFR 888.3040, 21 CFR 888.3030 Product Code: MAI, MBI Premarket Notification: K203495 Manufacturer: Arthrex, Inc. Trade Name: Arthrex SutureTak Suture Anchors Common Name: sut…
Arthrex, Inc.20211
*K140855Arthrex Suturetak Suture Anchors
Summary page 14
…Common Name: suture anchor Classification: Class II, 21 CFR 888.3040, 21 CFR 888.3030 Product Code: MAI, MBI Premarket Notification: K140855 Manufacturer: Arthrex, Inc. Trade Name: Arthrex PushLock™ Common Name: suture anchor Clas…
Arthrex, Inc.2014—
*K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family
Summary page 14
…e: suture anchor Classification: Class II, 21 CFR 888.3040, 21 CFR 888.3030 Product Code: HWC, JDR, MAI, MBI Premarket Notification: K061863 Manufacturer: Arthrex, Inc. Trade Name: Arthrex 2.5mm PushLock™ Common Name: Fastener; Sc…
Arthrex, Inc.2006—
*K063479Arthrex Pushlock
Summary page 14
…Fastener; Screw, Fixation, Bone Classification: Class II, 21 CFR 888.3040, 21 CFR 888.3030 Product Code: HWC, MAI, MBI Premarket Notification: K063479 Manufacturer: Arthrex, Inc. Trade Name: FOOTPRINT Ultra PK Suture Anchor Common Name: sut…
Arthrex, Inc.2006—
*K093897Smith & Nephew Footprint Ultra PK Suture Anchor
Summary page 14
…ltra PK Suture Anchor Common Name: suture anchor Classification: Class II, 21 CFR 888.3040 Product Code: MBI Premarket Notification: K093897 Manufacturer: Smith & Nephew, Inc., Endoscopy Division Trade Name: BIORAPTOR™ Knotless Suture Anchor C…
Smith & Nephew Inc., Endoscopy Div.20102
*K121018Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an
Summary page 15
…2 K231002 Premarket Notification: K121018 Manufacturer: Smith & Nephew, Inc. IV Device description All Javelot PEEK suture anchors are preassembled ont…
Smith & Nephew, Inc.2012—

Also cleared against K093228: 2 other devices →

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 44 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
  • 17 of the 114 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K093228.

How does its category compare?

All MBI devices

MBI 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

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
2007high 24 (2007) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MBI

3,826in 2025

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

What is it indicated for?

The Javelot PK-S suture anchor is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: -Bankart lesion repair -SLAP lesion repair -Acromioclavicular separation repair -Rotator cuff tear repair -Capsular shift or capsulolabral reconstruction -Biceps tenodesis -Deltoid repair Foot/Ankle: -Hallux Valgus repair -Medial or lateral instability repair/reconstruction -Achilles tendon repair/reconstruction -Midfoot…

Read the full statement (669 words)

The Javelot PK-S suture anchor is intended for the reattachment of soft tissue to bone for the following indications:

Shoulder:

-Bankart lesion repair

-SLAP lesion repair

-Acromioclavicular separation repair

-Rotator cuff tear repair

-Capsular shift or capsulolabral reconstruction

-Biceps tenodesis

-Deltoid repair

Foot/Ankle:

-Hallux Valgus repair

-Medial or lateral instability repair/reconstruction

-Achilles tendon repair/reconstruction

-Midfoot reconstruction

-Metatarsal ligament/tendon repair/reconstruction

Elbow:

-Ulnar or radial collateral ligament reconstruction

-Lateral epicondylitis repair

-Biceps tendon reattachment

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

The Javelot PK-S suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications:

Shoulder:

-Bankart repair

-SLAP lesion repair

-Acromioclavicular separation repair

-Rotator cuff repair

-Capsular shift or capsulolabral reconstruction

-Biceps tenodesis

-Deltoid repair

Foot/Ankle:

-Hallux Valgus reconstruction

-Medial stabilization

-Lateral stabilization

-Achilles tendon repair

-Mid-foot reconstruction

-Metatarsal ligament/ tendon repair

-Bunionectorny

Elbow:

-Ulnar/ radial collateral ligament reconstruction

-Biceps tendon reattachment

-Lateral epicondylitis repair

Hand/Wrist:

-Scapholunate ligament reconstruction

-Ulnar/Radial collateral ligament reconstruction

Knee:

-Medial collateral ligament repair

-Lateral collateral ligament repair

-Posterior oblique ligament repair

-Iliotibial band tenodesis

-Patellar tendon repairs

-Anterior cruciate ligament repair (4.75-5.5mm anchors only)

-Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5mm anchors only)

-Quadriceps tendon repair (4.75 mm anchors only)

-Meniscal root repair (4.75 mm anchors only)

Hip:

-Capsular Repair

-Acetabular labral repair

-Proximal hamstring repair (4.75-5.5mm anchors only)

-Gluteus Medius Repair (4.75-5.5mm anchors only)

The Javelot PK-P suture anchor is intended for the reattachment of soft tissue to bone for the following indications:

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

-Metatarsal ligament repair

-Hallux valgus reconstruction

-Digital tendon transfers

-Mid-foot reconstruction

Knee:

-Medial collateral ligament repair

-Lateral collateral ligament repair

-Patellar tendon repair

-Posterior oblique ligament repair

-Iliotibial band tenodesis

Hand/Wrist:

-Scapholunate ligament reconstruction

-Carpal ligament reconstruction

-Repair/Reconstruction of collateral ligaments

-Repair of flexor and extensor tendons at the PIP, DIP, and MCP joints for all digits

-Digital tendon transfers

Elbow:

-Biceps tendon reattachment

-Ulnar or radial collateral ligament reconstruction

Hip:

-Capsular repair

-Acetabular labral repair

The Javelot PK-P suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications:

Shoulder:

-Bankart repair

-SLAP lesion repair

-Acromioclavicular separation repair

-Rotator cuff repair

-Capsular shift or capsulolabral reconstruction

-Biceps tenodesis

-Deltoid repair

Foot/ Ankle:

-Hallux Valgus reconstruction

-Medial stabilization

-Lateral stabilization

-Achilles Tendon Repair

-Mid-foot reconstruction

-Metatarsal ligament repair/ tendon repair

-Digital tendon transfers (2.5mm anchor only)

-Bunionectomy (2.9-4.5mm anchors only)

Elbow:

-Ulnar or radial collateral ligament reconstructions

-Biceps tendon reattachment

-Lateral epicondylitis repair (2.9-4.5mm anchors only)

Hand/ Wrist:

-Scapholunate ligament reconstruction

-UInar collateral ligament reconstruction (2.9-4.5mm anchors only)

-Radial collateral ligament reconstruction (2.9-4.5mm anchors only)

-Carpal ligament reconstruction (2.5mm anchors only)

-Repair/Reconstruction of collateral ligaments (2.5mm anchors only)

-Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits (2.5mm anchors only)

-Digital tendon transfers (2.5mm anchors only)

Knee:

-Medial collateral ligament repair

-Lateral collateral ligament repair

-Posterior oblique ligament repair

-Iliotibial band tenodesis

-Patellar tendon repairs

Hip: (2.9-4.5mm anchors only)

-Acetabular labral repair

-Capsular repair

The Javelot PK-L suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications:

Shoulder:

-Bankart lesion repair

-SLAP lesion repair

-Acromioclavicular separation repair

-Rotator cuff tear repair

-Capsular shift or capsulolabral reconstruction

-Biceps tenodesis

-Deltoid repair

-Anterior shoulder instability (3.7mm anchors only)

Foot/ Ankle:

-Hallux Valgus repair

-Medial or lateral instability repair

-Midfoot reconstruction

-Metatarsal ligament/tendon repair/reconstruction

-Achilles tendon repair/reconstruction

-Bunionectomy (3.7mm anchors only)

Elbow:

-Ulnar or radial collateral ligament reconstruction

-Biceps tendon reattachment

-Lateral epicondylitis repair (3.7mm anchors only)

Hand/Wrist:

-Scapholunate ligament reconstruction

-Ulnar collateral ligament reconstruction

-Radial collateral ligament reconstruction

Knee:

-Medial collateral ligament repair

-Lateral collateral ligament repair

-Posterior oblique ligament repair

-Iliotibial band tenodesis

-Patellar tendon repair

Hip: (3.7mm anchors only)

-Hip capsule repair

Acetabular labrum reattachment/ reconstruction

Indications for use as stated in the FDA summary.

Also cleared against K093228

2 other devices cite the same predicate.

  • K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012
  • K100159Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 20104 recalls

More from Suzhou Endophix Co., Ltd.

4 FDA decisions under this applicant name. See the company

  • K232941Megaloop Button SystemSuzhou Endophix Co., Ltd. · 2024
  • K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd. · 2023
  • K230874Syntheface PEEK Interference Screw, Syntheface PEEK Screw SheathSuzhou Endophix Co., Ltd. · 2023

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K231002 · printed Nov 6, 2026

Cite this page

510(k) Report. “K231002: Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231002

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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