510(k) · Cleared

Cleared

Smith & Nephew Peek Interference Screw

K083226510(k) TraditionalCleared Jan 30, 200988-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

Smith & Nephew Endoscopy, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Jan 30, 2009 as substantially equivalent to K071586 (Smith & Nephew Inc., Endoscopy Division, 2007) and 1 other predicate after an 88-day review. Its family tree reaches back 5 generations to 1996. 9 later devices descend from it.

Decided: Jan 30, 2009
Review: 88 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 2

Its longest line of descent runs back 5 generations to K961555 (1996). 9 ancestors in all. 9 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 5 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
4 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
3 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
2 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
1 generation backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
This deviceK083226 Smith & Nephew Peek Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
Descendant · cites it directly · 4 of its ownK091093 Parcus Ppek CF Interference ScrewParcus Medical, LLC · 2009
Descendant · 2 generations on · 1 of its ownK170877 Parcus SLiK Fix ScrewParcus Medical · 2017
Descendant · cites it directly · 1 of its ownK140879 Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc. · 2014
Descendant · 2 generations on · 1 of its ownK111471 Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX…Medshape Solutions, Inc. · 2011 · Recalled
Descendant · 3 generations on · 0 of its ownK200428 Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc. · 2020

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2009high 2 (2011) · low 0 (2010)2026

Most influential descendants

Showing 5 of 9 · See all

K091093Parcus Ppek CF Interference ScrewParcus Medical, LLC · 2009 · cites it directly4descendants
K170877Parcus SLiK Fix ScrewParcus Medical · 2017 · 2 generations on1descendant
K140879Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc. · 2014 · cites it directly1descendant
K111471Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)Medshape Solutions, Inc. · 2011 · 2 generations on1descendant
K200428Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc. · 2020 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K961555	Acufex Tag Bioabsorbable Anchors	Acufex Microsurgical, Inc.	1996	—
−4	K031685	Tag Rod Bioraptor Suture Anchor 7209317, 7209318	Smith & Nephew, Inc.	2003	5
−3	K053344	Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…	Smith & Nephew, Inc.	2006	—
−2	K061154	Kinsa Suture Anchor	Smith & Nephew, Inc.	2006	—
−1	K071586	Bioraptor 2.3 PK Suture Anchor	Smith & Nephew Inc., Endoscopy Division	2007	1
0 (this device)	K083226	Smith & Nephew Peek Interference Screw	Smith & Nephew Endoscopy, Inc.	2009	—
+1	K091093	Parcus Ppek CF Interference Screw	Parcus Medical, LLC	2009	—
+2	K170877	Parcus SLiK Fix Screw	Parcus Medical	2017	—
+1	K140879	Biosure Healicoil PK Interference Screw	Smith & Nephew, Inc.	2014	—
+2	K111471	Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)	Medshape Solutions, Inc.	2011	1
+3	K200428	Multi-Drive Interference Screw System	Nvision Biomedical Technologies, Inc.	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2005	1	0
2006	1	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2011	2	0
2012	1	0
2013	1	0
2014	1	0
2015	1	0
2017	1	0
2020	1	0

FIG. 1 — Lineage of K083226, 1996–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K071586	Bioraptor 2.3 PK Suture Anchor Summary page 1 …in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew Bioraptor 2.3PK (K071586) and Arthrex Interference Screw (K062466) Page 28 of 95 === Pa…	Smith & Nephew Inc., Endoscopy Division	2007	1
*	K062466	Arthrex Interference Screw Summary page 1 …ic Technology to the following legally marketed device in commercial distribution: Smith & Nephew Bioraptor 2.3PK (K071586) and Arthrex Interference Screw (K062466) Page 28 of 95 E. Description of Device The Smit…	Arthrex, Inc.	2006	—

Also cleared against K071586: 22 other devices →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K091093	Parcus Ppek CF Interference Screw	Parcus Medical, LLC	2009	4
K140879	Biosure Healicoil PK Interference Screw	Smith & Nephew, Inc.	2014	1
K122596	Arthroscopic Surgical Instruments - Interference Screw Systems	Smith & Nephew, Inc.	2012	0
K113591	Cols Peek	Fournitures Hospitalieres Industrie	2011	0

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 13 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
3 of the 9 ancestors have a recall of any class.
Of its descendants, K091093 (Parcus Medical, LLC, 2009) has gone furthest, with 4 descendants of its own.
22 other devices also cite its predicate K071586.

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. 2009, this device’s year, is highlighted.

FDA decisions per year · MBI

27in 2025

2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	16	80	24	240
2008	10	69	6	338
2009	19	82	2	355
2010	17	76	3	291
2011	30	75	23	328
2012	24	94	6	371
2013	31	100	2	442
2014	23	101	0	504
2015	23	85	0	507
2016	17	94	0	795
2017	17	70	4	675
2018	16	91	2	1,072
2019	31	90	0	1,303
2020	35	83	1	1,454
2021	18	107	0	1,890
2022	19	64	0	1,591
2023	52	57	1	2,503
2024	22	30	1	3,779
2025	27	58	1	3,826
2026	30	63	0	—

What is it indicated for?

The Smith & Nephew PEEK Interference Screws are indicated for the reattachment of ligament, tendon or soft tissue to bone for the following: Shoulder: Bankart Repair, Anterior Shoulder Instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstruIction, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis Foot/Ankle: Hallux Valgus ,Lateral stabilization, Medial stabilization, Achilles Tendon…

Read the full statement (125 words)

The Smith & Nephew PEEK Interference Screws are indicated for the reattachment of ligament, tendon or soft tissue to bone for the following:

Shoulder:

Bankart Repair, Anterior Shoulder Instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstruIction, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis

Foot/Ankle:

Hallux Valgus ,Lateral stabilization, Medial stabilization, Achilles Tendon repair/recon, Midfoot reconstruction, Metatarsal Ligament/ tendon repair, Bunionectomy, Flexor Hullucis Longus repair, Tendon Transfers.

Elbow/Hand/Wrist:

Biceps Tendon Reattachment,Ulnar or Radial Collateral Ligament Recon, Lateral Epicondylitis Repair, Scapholunate Ligament Recon, Tendon Transfers, Carpometacarpal Joint Arthroplasty, Carpal Ligament Recon / Repair

Knee:

Medial or Lateral Collateral ligament, Posterior oblique ligament, Vastus medialis obliquous advancement, iliotibial band tenodesis, ACL Repairs, MCL Repairs, LCL Repairs, Patellar tendon repair, Posterior Oblique ligament repair

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083226 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083226: Smith & Nephew Peek Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083226

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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