510(k) Report

510(k) · Cleared

Cleared

Mini Quickanchor and Quickanchor Plus with Orthocord

K071257510(k) TraditionalCleared Jun 29, 200756-day reviewClass II21 CFR 888.3030

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 Jun 29, 2007 as substantially equivalent to K930892 (Mitek Surgical Products, Inc., 1994) and 4 other predicates after a 56-day review. Its family tree reaches back 3 generations to 1992. 8 later devices descend from it.

Decided
Jun 29, 2007
Review
56 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K921873 (1992). 10 ancestors in all. 8 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 2 other ancestors1999: 1 other ancestor1994: 1 other ancestor2002: 1 other ancestor1995: 1 other ancestor2001: 1 other ancestor2021: 1 descendant cleared2012: 2 descendants cleared2020: 1 descendant cleared2013: 1 descendant cleared2015: 1 descendant cleared2026: 1 descendant cleared2024: 1 descendant clearedK921873 · Quickanchor, Modification · Mitek Surgical Products, Inc. · 1992K992487 · Mitek Mini Quickanchor Plus · Mitek Products · 1999K030995 · Minilok Quickanchor Plus · Mitek Worldwide · 20031990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 2 descendants K030995 · Minilok Quickanchor Plus · Mitek Worldwide · 2003K992487 · Mitek Mini Quickanchor Plus · Mitek Products · 1999K921873 · Quickanchor, Modification · Mitek Surgical Products, Inc. · 19920
  1. Root · 3 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
  2. 2 generations backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
  3. 1 generation backK030995 Minilok Quickanchor PlusMitek Worldwide · 2003
  4. This deviceK071257 Mini Quickanchor and Quickanchor Plus with OrthocordDepuy Mitek, A Johnson & Johnson Company · 2007
  5. Descendant · cites it directly · 1 of its ownK212381 VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021
  6. Descendant · cites it directly · 1 of its ownK201636 Hercules Suture Anchor SystemIn2bones USA, LLC · 2020
  7. Descendant · 2 generations on · 0 of its ownK253538 TeKBrace Knotless AnchorTheramicro · 2026
  8. Descendant · 2 generations on · 0 of its ownK242296 VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002)…Ortho-Design (Pty), Ltd. · 2024
  9. Descendant · cites it directly · 0 of its ownK143473 Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE…Cayenne Medical, Inc. · 2015

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2012: 22013: 12015: 12020: 12021: 12024: 12026: 1
2012high 2 (2012) · low 0 (2014)2026

Most influential descendants

Showing 5 of 8 · See all
  • K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021 · cites it directly1descendant
  • K201636Hercules Suture Anchor SystemIn2bones USA, LLC · 2020 · cites it directly1descendant
  • K253538TeKBrace Knotless AnchorTheramicro · 2026 · 2 generations on0descendants
  • K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd. · 2024 · 2 generations on0descendants
  • K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles…Cayenne Medical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K921873Quickanchor, ModificationMitek Surgical Products, Inc.1992—
−2K992487Mitek Mini Quickanchor PlusMitek Products1999—
−1K030995Minilok Quickanchor PlusMitek Worldwide2003—
0 (this device)K071257Mini Quickanchor and Quickanchor Plus with OrthocordDepuy Mitek, A Johnson & Johnson Company2007—
+1K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.2021—
+1K201636Hercules Suture Anchor SystemIn2bones USA, LLC2020—
+2K253538TeKBrace Knotless AnchorTheramicro2026—
+2K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™…Ortho-Design (Pty), Ltd.2024—
+1K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with…Cayenne Medical, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199910
200110
200210
200420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201310
201510
202010
202110
202410
202610
FIG. 1 — Lineage of K071257, 1992–2026Source: 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 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? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K930892Mitek Mini Anchor, Modification
Summary page 1
…ickAnchor w/ Orthocord, and Orthocord Suture size 2-0, are substantially equivalent to: Mini QuickAnchor Plus (K930892, K992487 and K992623); MINILOK QuickAnchor Plus (K030995); and Orthocord Suture Size 2 (K043298,…
Mitek Surgical Products, Inc.1994—
*K992487Mitek Mini Quickanchor Plus
Summary page 1
…w/ Orthocord, and Orthocord Suture size 2-0, are substantially equivalent to: Mini QuickAnchor Plus (K930892, K992487 and K992623); MINILOK QuickAnchor Plus (K030995); and Orthocord Suture Size 2 (K043298,…
Mitek Products1999—
*K992623Mitek Mini Anchor
Summary page 1
…Orthocord, and Orthocord Suture size 2-0, are substantially equivalent to: Mini QuickAnchor Plus (K930892, K992487 and K992623); MINILOK QuickAnchor Plus (K030995); and Orthocord Suture Size 2 (K043298,…
Mitek Products1999—
*K030995Minilok Quickanchor Plus
Summary page 1
…e substantially equivalent to: Mini QuickAnchor Plus (K930892, K992487 and K992623); MINILOK QuickAnchor Plus (K030995); and Orthocord Suture Size 2 (K043298, K04004) manufactured by DePuy Mitek.…
Mitek Worldwide2003—
*K043298Blue Orthocord Suture
Summary page 1
…Mini QuickAnchor Plus (K930892, K992487 and K992623); MINILOK QuickAnchor Plus (K030995); and Orthocord Suture Size 2 (K043298, K04004) manufactured by DePuy Mitek. Bone anchors/screws are classifie…
Depuy Mitek20046
Kept off the family treeK040004FDA’s K040004 is Orthocord Suture
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Depuy Mitek20041

Also cleared against K930892: 8 other devices →

What descends from it? (8)

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211
K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201
K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles…Cayenne Medical, Inc.20150
K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company20130
K121356Micro/Mini N-PK (H) Bone AnchorAnulex Technologies, Inc.20120
K121354Micro/Mini N-PK (F) Bone AnchorAnulex Technologies, Inc.20120

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 15 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
  • 2 of the 10 ancestors have a recall of any class.
  • Of its descendants, K212381 (Ortho-Design (Pty), Ltd., 2021) has gone furthest, with 1 descendant of its own.
  • 8 other devices also cite its predicate K930892.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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 MINILOK QuickAnchor Plus is indicated for use in soft tissue to bone fixation in

association with adequate postoperative immobilization as follows:

Wrist: Scapholunate ligament reconstruction.

Hand: Thumb ulnar or radial collateral ligament.

Foot: Hallux valgus reconstruction.

Ankle: Midfoot reconstruction.

The MINI QuickAnchor Plus is indicated for use in soft tissue to bone fixation in

association with adequate postoperative immobilization as follows:

Shoulder: Bankart Repair

Wrist: Scapholunate ligament reconstruction.

Hand: Thumb ulnar or radial collateral ligament.

Foot: Hallux valgus reconstruction.

Ankle: Midfoot reconstruction.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K071257: Mini Quickanchor and Quickanchor Plus with Orthocord.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071257

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