510(k) Report

510(k) · Cleared

Cleared

Renovo Suture Anchors, Models 100-2001 Thru 100-5502X

K071520510(k) TraditionalCleared Aug 10, 200767-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

Core Essence Orthopaedics, LLC · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Aug 10, 2007 as substantially equivalent to K962511 (Mitek Products, 1996) and 12 other predicates after a 67-day review. Its family tree reaches back 3 generations to 1996. 7 later devices descend from it.

Decided
Aug 10, 2007
Review
67 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
13

Its longest line of descent runs back 3 generations to K961555 (1996). 19 ancestors in all, the oldest K904436 (1990). 7 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2001: 1 other ancestor1998: 3 other ancestors1997: 1 other ancestor1996: 4 other ancestors1995: 2 other ancestors1993: 1 other ancestor2002: 1 other ancestor1994: 1 other ancestor1990: 1 other ancestor2020: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared2011: 1 descendant cleared2014: 2 descendants cleared2015: 1 descendant clearedK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 1996K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalledK053344 · Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor · Smith & Nephew, Inc. · 20061990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 12 other ancestors2 generations back: 4 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K053344 · Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor · Smith & Nephew, Inc. · 2006K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalledK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 19960
  1. Root · 3 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. 2 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
  3. 1 generation backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
  4. This deviceK071520 Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007
  5. Descendant · cites it directly · 3 of its ownK101126 Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010
  6. Descendant · 2 generations on · 1 of its ownK140127 Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014
  7. Descendant · cites it directly · 1 of its ownK090128 Tac-Tite (TM)Core Essence Orthopaedics, Inc. · 2009
  8. Descendant · cites it directly · 0 of its ownK193377 TopLock Anchor SystemFusion Orthopedics, LLC · 2020
  9. Descendant · 3 generations on · 0 of its ownK143582 Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide…Resorba Medical GmbH · 2015

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 12014: 22015: 12020: 1
2009high 2 (2014) · low 0 (2012)2026

Most influential descendants

Showing 5 of 7 · See all
  • K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010 · cites it directly3descendants
  • K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014 · 2 generations on1descendant
  • K090128Tac-Tite (TM)Core Essence Orthopaedics, Inc. · 2009 · cites it directly1descendant
  • K193377TopLock Anchor SystemFusion Orthopedics, LLC · 2020 · cites it directly0descendants
  • K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH · 2015 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc.1996—
−2K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc.20035
−1K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…Smith & Nephew, Inc.2006—
0 (this device)K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC2007—
+1K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc.2010—
+2K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC2014—
+1K090128Tac-Tite (TM)Core Essence Orthopaedics, Inc.2009—
+1K193377TopLock Anchor SystemFusion Orthopedics, LLC2020—
+3K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199310
199410
199520
199640
199710
199830
200110
200210
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201110
201420
201510
202010
FIG. 1 — Lineage of K071520, 1996–2020Source: 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 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? (13)

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
*K962511Mitek Micro Anchor
Summary page 3
…Nephew States Surgical K962511 K962397 K012503 K971723 K053344 k040594 K962793…
Mitek Products1996—
*K962793Mitek Micro Anchor
Summary page 3
…Surgical K962511 K962397 K012503 K971723 K053344 k040594 K962793 K926384 K973775 K960516 K972326 K982420 K943806 In conclusion: Core Ess…
Mitek Products1996—
*K982420Mitek Micro Anchor
Summary page 3
…K962397 K012503 K971723 K053344 k040594 K962793 K926384 K973775 K960516 K972326 K982420 K943806 In conclusion: Core Essence Orthopaedics reNOVO suture anchors are substantially equivalent to t…
Mitek Products1998—
*K926384Statak & Mini-Statak Soft Tissue Attachment Device
Summary page 3
…Surgical K962511 K962397 K012503 K971723 K053344 k040594 K962793 K926384 K973775 K960516 K972326 K982420 K943806 In conclusion: Core Essence Orthopaedics…
Zimmer, Inc.1993—
*K962397Statak Soft Tissue Attachment Device
Summary page 3
…Nephew States Surgical K962511 K962397 K012503 K971723 K053344 k040594 K962793 K926384 K973775…
Zimmer, Inc.1996—
*K012503Metal Screw Anchor
Summary page 3
…States Surgical K962511 K962397 K012503 K971723 K053344 k040594 K962793 K926384 K973775 K960516 K972326 K982420…
Biomet Manufacturing, Inc.2001—
*K973775Harpoon Suture Anchors
Summary page 3
…Surgical K962511 K962397 K012503 K971723 K053344 k040594 K962793 K926384 K973775 K960516 K972326 K982420 K943806 In conclusion: Core Essence Orthopaedics reNOVO suture…
Biomet, Inc.1998—
*K943806Harpoon Suture Anchors
Summary page 3
…K012503 K971723 K053344 k040594 K962793 K926384 K973775 K960516 K972326 K982420 K943806 In conclusion: Core Essence Orthopaedics reNOVO suture anchors are substantially equivalent to the currently marked devices and…
Biomet, Inc.1995—
*K971723Fastak Suture Anchor (11.7MM)/(7.5MM)
Summary page 3
…Surgical K962511 K962397 K012503 K971723 K053344 k040594 K962793 K926384 K973775 K960516 K972326 K982420…
Arthrex, Inc.1997—
*K960516Fastak Suture Anchor
Summary page 3
…511 K962397 K012503 K971723 K053344 k040594 K962793 K926384 K973775 K960516 K972326 K982420 K943806 In conclusion: Core Essence Orthopaedics reNOVO suture anchors are subs…
Arthrex, Inc.1996—
*K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor
Summary page 3
…Surgical K962511 K962397 K012503 K971723 K053344 k040594 K962793 K926384 K973775 K960516 K972326 K982420 K943806 In…
Smith & Nephew, Inc.2006—
*K972326Peba Anchor/Suture Combination
Summary page 3
…K962397 K012503 K971723 K053344 k040594 K962793 K926384 K973775 K960516 K972326 K982420 K943806 In conclusion: Core Essence Orthopaedics reNOVO suture anchors are substantially equiva…
Orthopaedic Biosystems, Ltd.19981
*K040594Herculon Soft Tissue Reattachment System
Summary page 3
…Surgical K962511 K962397 K012503 K971723 K053344 k040594 K962793 K926384 K973775 K960516 K972326 K982420 K943806 In conclusion:…
United States Surgical, A Division of Tyco Healthc2004—

Also cleared against K962511: 6 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc.20103
K090128Tac-Tite (TM)Core Essence Orthopaedics, Inc.20091
K193377TopLock Anchor SystemFusion Orthopedics, LLC20200

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 11 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
  • 2 of the 19 ancestors have a recall of any class.
  • Of its descendants, K101126 (Core Essence Orthopaedics, Inc., 2010) has gone furthest, with 3 descendants of its own.
  • 6 other devices also cite its predicate K962511.

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. 2007, 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?

reNOVO Suture Anchors are intended to secure soft tissue to bone of:

The Shoulder:

Bankart Repair

SLAP Lesion Repair

Acromio-Clavicular Separation

Roatator Cuff Repair

Capsule Repair

Biceps Tenodesis

Deltoid Repair

The Elbow:

Ulnar or Radial Collateral Ligament Reconstruction

Bicep Tendon Reconstruction

Tennis Elbow Repair

The Hand and Wrist:

Scapholunate Ligament Reconstruction

Ulnar / Radial Collateral Ligament Reconstruction

Collateral Ligaments around the PIP, DIP and MCP Joints

Flexor and Extensor Tendons

The Ankle and Foot:

Lateral Stabilization

Medial Stabilization

Achilles Tendon Repair / Reconstruction

Hallux Valgus Reconstruction

Mid and Rear Foot Reconstruction

Indications for use as stated in the FDA summary.

Also cleared against K962511

6 other devices cite the same predicate.

  • K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010
  • K080352Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+ Anchor with #3-0 Orthocord SutureDepuy Mitek, A Johnson & Johnson Company · 2008
  • K032078Mitek Micro QuickanchorMitek Worldwide · 2003
  • K993575Resolve QuickanchorMitek Products · 1999
  • K993327Talon Anchor Snap-PakMitek Products · 1999
  • K993261Talon Anchor Snap-PakMitek Products · 1999

More from Core Essence Orthopaedics, LLC

3 FDA decisions under this applicant name. See the company

  • K081060Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5Core Essence Orthopaedics, LLC · 2008
  • K071477Reverto 55 and 37 Shape Memory StaplesCore Essence Orthopaedics, LLC · 2007

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/K071520 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071520: Renovo Suture Anchors, Models 100-2001 Thru 100-5502X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071520

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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