510(k) Report

510(k) · Cleared

Cleared

Smith & Nephew Phoenix 5.0 Allograft Anchor Kit

K011985510(k) TraditionalCleared Nov 2, 2001129-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

Smith & Nephew, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Nov 2, 2001 as substantially equivalent to K982963 (Orthopaedic Biosystems, Ltd., 1998) and 1 other predicate after a 129-day review. Its family tree reaches back 4 generations to 1990. 3 later devices descend from it.

Decided
Nov 2, 2001
Review
129 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K904436 (1990). 12 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 2 other ancestors1996: 2 other ancestors1997: 1 other ancestor1993: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor2004: 1 descendant cleared2006: 2 descendants clearedK904436 · Quickanchor (TM) · Mitek Surgical Products, Inc. · 1990K962397 · Statak Soft Tissue Attachment Device · Zimmer, Inc. · 1996K973015 · Multitak SS Suture System · Bonutti Research · 1997K993115 · Multitak SS · Bonutti Research, Inc. · 19991990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K993115 · Multitak SS · Bonutti Research, Inc. · 1999K973015 · Multitak SS Suture System · Bonutti Research · 1997K962397 · Statak Soft Tissue Attachment Device · Zimmer, Inc. · 1996K904436 · Quickanchor (TM) · Mitek Surgical Products, Inc. · 19900
  1. Root · 4 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
  2. 3 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
  3. 2 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
  4. 1 generation backK993115 Multitak SSBonutti Research, Inc. · 1999
  5. This deviceK011985 Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc. · 2001
  6. Descendant · cites it directly · 1 of its ownK042038 MTF Allograft AnchorMusculoskeletal Transplant Foundation · 2004
  7. Descendant · cites it directly · 0 of its ownK061498 Allofix Anchor, 5.0 MM AnchorMusculoskeletal Transplant Foundation · 2006 · Recalled
  8. Descendant · 2 generations on · 0 of its ownK053339 Allofix AnchorMusculoskeletal Transplant Foundation · 2006

Most influential descendants

Showing 3 of 3 · See all
  • K042038MTF Allograft AnchorMusculoskeletal Transplant Foundation · 2004 · cites it directly1descendant
  • K061498Allofix Anchor, 5.0 MM AnchorMusculoskeletal Transplant Foundation · 2006 · cites it directly0descendants
  • K053339Allofix AnchorMusculoskeletal Transplant Foundation · 2006 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K904436Quickanchor (TM)Mitek Surgical Products, Inc.1990—
−3K962397Statak Soft Tissue Attachment DeviceZimmer, Inc.1996—
−2K973015Multitak SS Suture SystemBonutti Research1997—
−1K993115Multitak SSBonutti Research, Inc.1999—
0 (this device)K011985Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc.2001—
+1K042038MTF Allograft AnchorMusculoskeletal Transplant Foundation2004—
+1K061498Allofix Anchor, 5.0 MM AnchorMusculoskeletal Transplant Foundation20061
+2K053339Allofix AnchorMusculoskeletal Transplant Foundation2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
199510
199620
199710
199820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200620
FIG. 1 — Lineage of K011985, 1990–2006Source: 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 MAI? 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 MAI device

  1. #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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? (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
*K982963Polymer Threaded Anchor / Suture Combination
Summary page 1
…Anchor Kit Common Name; Soft Tissue Suture Anchor Classification Name: Unclassified D. Predicate Devices Smith & Nephew Preloaded PRC5 5.0 mm Polyacetal Suture Anchor (K982963) Multitak SS Bone Anchor (K993115) E. Description of Device The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit composed of mac…
Orthopaedic Biosystems, Ltd.1998—
*K993115Multitak SS
Summary page 1
…e Suture Anchor Classification Name: Unclassified D. Predicate Devices Smith & Nephew Preloaded PRC5 5.0 mm Polyacetal Suture Anchor (K982963) Multitak SS Bone Anchor (K993115) E. Description of Device The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit composed of machined cortical bone. The anchor is…
Bonutti Research, Inc.1999—

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K042038MTF Allograft AnchorMusculoskeletal Transplant Foundation20041
K061498Allofix Anchor, 5.0 MM AnchorMusculoskeletal Transplant Foundation20060

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 5 companies; a new generation was cleared every 2.2 years on median.
  • 1 of the 12 ancestors has a recall of any class.
  • Of its descendants, K042038 (Musculoskeletal Transplant Foundation, 2004) has gone furthest, with 1 descendant of its own.

How does its category compare?

All MAI devices

MAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAI

8in 2025

2007: 42008: 32009: 92010: 42011: 92012: 62013: 62014: 42015: 52016: 32017: 92018: 132019: 92020: 92021: 82022: 62023: 82024: 72025: 82026 (partial year): 5
2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007: 100 days median2008: 83 days median2009: 74 days median2010: 122 days median2011: 90 days median2012: 56 days median2013: 135 days median2014: 86 days median2015: 95 days median2016: 191 days median2017: 113 days median2018: 108 days median2019: 41 days median2020: 78 days median2021: 115 days median2022: 136 days median2023: 34 days median2024: 53 days median2025: 54 days median2026 (partial year): 69 days median
2007high 191 (2016) · low 34 (2023)2026

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

Recalls per year · MAI

40in 2020

2011: 52012: 102019: 22020: 402026 (partial year): 1
2007high 40 (2020) · low 0 (2007)2026

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

Adverse event reports per year · MAI

2,148in 2025

2007: 2722008: 1722009: 882010: 892011: 1292012: 1712013: 1662014: 1492015: 1822016: 3012017: 4782018: 1,5902019: 1,2482020: 9572021: 1,2672022: 1,4252023: 1,7182024: 2,3002025: 2,148
2007high 2,300 (2024) · low 88 (2009)2025

MAUDE reports naming product code MAI, 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
200741000272
20083830172
2009974088
20104122089
20119905129
201265610171
201361350166
20144860149
20155950182
201631910301
201791130478
20181310801,590
201994121,248
202097840957
2021811501,267
2022613601,425
202383401,718
202475302,300
202585402,148
20265691—

What is it indicated for?

The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit is intended for use only for the fixation of soft tissue to bone for the following indications: Shoulder: Bankart lesion repairs SLAP lesion repairs Acromioclavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs Foot and Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon…

Read the full statement (115 words)

The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit is intended for use only for the fixation of soft tissue to bone for the following indications:

Shoulder:

Bankart lesion repairs

SLAP lesion repairs

Acromioclavicular separation repairs

Rotator cuff tear repairs

Capsular shift or capsulolabral reconstructions

Biceps tenodesis

Deltoid repairs

Foot and Ankle:

Hallux valgus repairs

Medial or lateral instability repairs/reconstructions

Achilles tendon repairs/reconstructions

Midfoot reconstructions

Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist, and Hand:

Scapholunate ligament reconstructions

Ulnar or radial collateral ligament reconstructions

Lateral epicondylitis repair

Biceps tendon reattachment

Knee:

Extra-capsular repairs:

a. medial collateral ligament

b. lateral collateral ligament

c. posterior oblique ligament

Iliotibial band tenodesis

Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

Recent decisions in MAI

The MAI category page

  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026

https://510kreport.com/device/K011985 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011985: Smith & Nephew Phoenix 5.0 Allograft Anchor Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011985

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026