510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Bioknotless and Lupine Plus Anchors

K062170510(k) SpecialCleared Aug 22, 200622-day reviewClass II21 CFR 888.3030Recalls 7

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

Depuy Mitek, A Johnson & Johnson Company · JDR Staple, Fixation, Bone

Cleared on Aug 22, 2006 as substantially equivalent to K002639 (Mitek Products, 2001) and 1 other predicate after a 22-day review. Its family tree reaches back 3 generations to 2001. 58 later devices descend from it. It has been recalled 7 times.

Decided
Aug 22, 2006
Review
22 days
Class
Class II
Product code
JDR
Recalls
7
Predicates
2

Its longest line of descent runs back 3 generations to K002639 (2001). 58 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2019: 4 descendants cleared2011: 5 descendants cleared2008: 2 descendants cleared2013: 7 descendants cleared2009: 1 descendant cleared2012: 1 descendant cleared2017: 4 descendants cleared2010: 1 descendant cleared2025: 3 descendants cleared2018: 5 descendants cleared2015: 2 descendants cleared2020: 3 descendants cleared2023: 4 descendants cleared2014: 3 descendants cleared2021: 5 descendants cleared2024: 3 descendants cleared2022: 1 descendant cleared2026: 3 descendants clearedK002639 · Bioknotless Anchor · Mitek Products · 2001 · recalledK040827 · Panalok Loop Anchor · Depuy Mitek, A Johnson & Johnson Company · 2004 · recalledK050771 · Lupine Loop · Depuy Mitek, A Johnson & Johnson Company · 2005200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 15 descendants4 generations forward: 13 descendants5 generations forward: 18 descendants6 generations forward: 5 descendants7 generations forward: 1 descendant K050771 · Lupine Loop · Depuy Mitek, A Johnson & Johnson Company · 2005K040827 · Panalok Loop Anchor · Depuy Mitek, A Johnson & Johnson Company · 2004 · recalledK002639 · Bioknotless Anchor · Mitek Products · 2001 · recalled0+5
  1. Root · 3 generations backK002639 Bioknotless AnchorMitek Products · 2001 · Recalled
  2. 2 generations backK040827 Panalok Loop AnchorDepuy Mitek, A Johnson & Johnson Company · 2004 · Recalled
  3. 1 generation backK050771 Lupine LoopDepuy Mitek, A Johnson & Johnson Company · 2005
  4. This deviceK062170 Bioknotless and Lupine Plus AnchorsDepuy Mitek, A Johnson & Johnson Company · 2006
  5. Descendant · cites it directly · 57 of its ownK070925 Modification to: Bioknotless BR Anchor / Lupine BR AnchorDepuy Mitek, A Johnson & Johnson Company · 2007 · Recalled
  6. Descendant · 2 generations on · 44 of its ownK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
  7. Descendant · 3 generations on · 25 of its ownK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
  8. Descendant · 3 generations on · 24 of its ownK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
  9. Descendant · 3 generations on · 15 of its ownK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011

Showing 5 of 58 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22009: 12010: 12011: 52012: 12013: 72014: 32015: 22017: 42018: 52019: 42020: 32021: 52022: 12023: 42024: 32025: 32026: 3
2007high 7 (2013) · low 0 (2016)2026

Most influential descendants

Showing 5 of 58 · See all
  • K070925Modification to: Bioknotless BR Anchor / Lupine BR AnchorDepuy Mitek, A Johnson & Johnson Company · 2007 · cites it directly57descendants
  • K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · 2 generations on44descendants
  • K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company · 2009 · 3 generations on25descendants
  • K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…Depuy Mitek, A Johnson & Johnson Company · 2010 · 3 generations on24descendants
  • K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company · 2011 · 3 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K002639Bioknotless AnchorMitek Products20012
−2K040827Panalok Loop AnchorDepuy Mitek, A Johnson & Johnson Company200417
−1K050771Lupine LoopDepuy Mitek, A Johnson & Johnson Company2005—
0 (this device)K062170Bioknotless and Lupine Plus AnchorsDepuy Mitek, A Johnson & Johnson Company2006—
+1K070925Modification to: Bioknotless BR Anchor / Lupine BR AnchorDepuy Mitek, A Johnson & Johnson Company200711
+2K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company20081
+3K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model…Depuy Mitek, A Johnson & Johnson Company20092
+3K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon…Depuy Mitek, A Johnson & Johnson Company2010—
+3K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend…Depuy Mitek, A Johnson & Johnson Company2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
200910
201010
201150
201210
201370
201430
201520
201740
201850
201940
202030
202150
202210
202340
202430
202530
202630
FIG. 1 — Lineage of K062170, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 JDR? 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 JDR device

  1. #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K002639Bioknotless Anchor
Summary page 1
…otless Anchor / Lupine Anchor Substantial Equivalence Bioknotless Plus Anchor is substantially equivalent to: Bioknotless Anchor, K002639, manufactured by DePuy Mitek. Lupine Plus Anchor is substantially equivalent to:…
Mitek Products20012
*K050771Lupine Loop
Summary page 1
…r, K002639, manufactured by DePuy Mitek. Lupine Plus Anchor is substantially equivalent to: Lupine Anchor, K050771, manufactured by DePuy Mitek Device Classification Bone anchors/screws are classified by the FDA as Class 11 Medical…
Depuy Mitek, A Johnson & Johnson Company2005—

Also cleared against K002639: 5 other devices →

What descends from it? (58)

See all 58

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070925Modification to: Bioknotless BR Anchor / Lupine BR AnchorDepuy Mitek, A Johnson & Johnson Company200757

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 13, 2023Class IIZ-1678-2023Use errorIFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS¿ Anchor…
Apr 13, 2023Class IIZ-1679-2023Use errorIFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS¿ Anchor…
Apr 13, 2023Class IIZ-1680-2023Use errorIFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS¿ Anchor…
Apr 13, 2023Class IIZ-1677-2023Use errorIFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS¿ Anchor…
Apr 13, 2023Class IIZ-1681-2023Use errorIFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS¿ Anchor…
Oct 31, 2011Not classifiedZ-0316-2012Employee errorIncorrect suture configuration
Oct 31, 2011Not classifiedZ-0315-2012Employee errorIncorrect suture configuration

The 5 latest of 7 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K070925 (Depuy Mitek, A Johnson & Johnson Company, 2007) has gone furthest, with 57 descendants of its own.
  • 5 other devices also cite its predicate K002639.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDR

3in 2025

2007: 82008: 52010: 22011: 12012: 12013: 92014: 112015: 72016: 62017: 92018: 82019: 52020: 42021: 32022: 52023: 92024: 42025: 32026 (partial year): 2
2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007: 70 days median2008: 89 days median2013: 137 days median2014: 97 days median2015: 111 days median2016: 101 days median2017: 172 days median2018: 107 days median2019: 149 days median2020: 161 days median2021: 62 days median2022: 107 days median2023: 72 days median2024: 29 days median2025: 65 days median
2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

2008: 12015: 12018: 12020: 12022: 112026 (partial year): 2
2007high 11 (2022) · low 0 (2007)2026

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

Adverse event reports per year · JDR

314in 2025

2007: 32008: 142009: 102010: 352011: 622012: 342013: 272014: 492015: 482016: 762017: 1162018: 2392019: 2422020: 2342021: 2102022: 2022023: 1752024: 2062025: 314
2007high 314 (2025) · low 3 (2007)2025

MAUDE reports naming product code JDR, 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
200787003
2008589114
20090—010
20102—035
20111—062
20121—034
20139137027
20141197049
20157111148
20166101076
201791720116
201881071239
201951490242
202041611234
20213620210
2022510711202
20239720175
20244290206
20253650314
20262—2—

What is it indicated for?

The Bioknotless Plus Anchor with is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER 1. Bankart repair 2. SLAP lesion repair 3. Rotator cuff repair 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus 5. Biceps tenodesis 6. Acromio-clavicular…

Read the full statement (326 words)

The Bioknotless Plus Anchor with is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:

OPEN PROCEDURES SHOULDER

1. Bankart repair

2. SLAP lesion repair

3. Rotator cuff repair

4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site

4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus

5. Biceps tenodesis

6. Acromio-clavicular separation

7. Deltoid repair

ELBOW

1. Biceps tendon reattachment

2. Tennis elbow repair

ANKLE

I. Achilles tendon repair/reconstruction

2. Lateral stabilization

3. Medial stabilization at the medial talus site

Foot: Hallux Valgus reconstruction

4. Midfoot reconstruction

KNEE

1. Medial collateral ligament repair

2. Lateral collateral ligament repair

3. Joint capsule closure to anterior proximal tibia

4. Posterior oblique ligament or joint capsule to tibia repair

5. Extra capsular reconstruction / HE tenodesis

6. Patellar ligament and tendon avulsion repairs.

ARTHROSCOPIC PROCEDURES SHOULDER

1. Bankart repair

2. SLAP lesion repair

3. Rotator cuff repair

4. Capsule shift repair (glenoid rim)

The Lupines Plus The Lupine Loop Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:

OPEN PROCEDURES SHOULDER

I. Bankart repair

2. SLAP lesion repair

3. Rotator cuff repair

4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site

4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus

5. Biceps tenodesis

6. Acromio-clavicular separation

7. Deltoid repair

ELBOW

L. Biceps tendon reattachment

2. Tennis elbow repair

ANKLE

I. Achilles tendon repair/reconstruction

2. Lateral stabilization

3. Medial stabilization at the medial talus site

Foot: Hallux Valgus reconstruction

4. Midfoot reconstruction

KNEE

1. Medial collateral ligament repair

2. Lateral collateral ligament repair

3. Joint capsule closure to anterior proximal tibia

4. Posterior oblique ligament orjoint capsule to tibia repair

5. Extra capsular reconstruction / ITB tenodesis

6. Patellar ligament and tendon avulsion repairs.

ARTHROSCOPIC PROCEDURES

SHOULDER

t. Bankart repair

2. SLAP lesion repair

3. Rotator cuff repair

4. Capsule shift repair (glenoid rim)

Indications for use as stated in the FDA summary.

Also cleared against K002639

5 other devices cite the same predicate.

  • K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009
  • K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
  • K041064Bioknotless RC AnchorDepuy Mitek · 2004
  • K041065Panalok RC Loop AnchorDepuy Mitek · 2004
  • K040827Panalok Loop AnchorDepuy Mitek, A Johnson & Johnson Company · 200417 recalls

More from Depuy Mitek, A Johnson & Johnson Company

58 FDA decisions under this applicant name. See the company

  • K143660Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2015
  • K1425744.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3…Depuy Mitek, A Johnson & Johnson Company · 2014
  • K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company · 2014
  • K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek Anchor with Permacord…Depuy Mitek, A Johnson & Johnson Company · 2014
  • K1337944.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix Advance BR Anchor…Depuy Mitek, A Johnson & Johnson Company · 2014

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The JDR category page

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https://510kreport.com/device/K062170 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062170: Bioknotless and Lupine Plus Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062170

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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