510(k) · Cleared

Cleared

Smith & Nephew Suretac - Expanded Indications II

K020948510(k) TraditionalCleared Oct 9, 2002198-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. · JDR Staple, Fixation, Bone

Cleared on Oct 9, 2002 as substantially equivalent to K911837 (Acufex Microsurgical, Inc., 1991) and 1 other predicate after a 198-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.

Decided: Oct 9, 2002
Review: 198 days
Class: Class II
Product code: JDR
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K911837 (1991). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
This deviceK020948 Smith & Nephew Suretac - Expanded Indications IISmith & Nephew, Inc. · 2002
Descendant · cites it directly · 0 of its ownK023417 Suretac Iii, Models 7209900, 7209901Smith & Nephew, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all

K023417Suretac Iii, Models 7209900, 7209901Smith & Nephew, Inc. · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K911837	Suretac Polyglyconate Absorbable Fixation Device	Acufex Microsurgical, Inc.	1991	—
0 (this device)	K020948	Smith & Nephew Suretac - Expanded Indications II	Smith & Nephew, Inc.	2002	—
+1	K023417	Suretac Iii, Models 7209900, 7209901	Smith & Nephew, Inc.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K020948, 1991–2002Source: 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 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 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K911837	Suretac Polyglyconate Absorbable Fixation Device Summary page 1 …ce Name Classification Name: Smooth or Threaded Metallic Bone Fixation Fastener (JDR) 7.5 Predicate Smith & Nephew, SURETAC@FixationDevice (K911837) Legally Smith & Nephew, SURETAC@Expanded Indication (K 93 18 19) Marketed Devices 7.6 Device The PGNTMC…	Acufex Microsurgical, Inc.	1991	—
*	K931519	Acufex Suretac Our reading of the summary gave K931819, FDA’s number for Carapace Suture Removal Trays (Carapace, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SURETAC Expanded Indication”.	Acufex Microsurgical, Inc.	1994	—

Also cleared against K911837: 6 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K023417	Suretac Iii, Models 7209900, 7209901	Smith & Nephew, Inc.	2002	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?

None of the 2 ancestors has a recall.
Of its descendants, K023417 (Smith & Nephew, Inc., 2002) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K911837.

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

2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	70	0	3
2008	5	89	1	14
2009	0	—	0	10
2010	2	—	0	35
2011	1	—	0	62
2012	1	—	0	34
2013	9	137	0	27
2014	11	97	0	49
2015	7	111	1	48
2016	6	101	0	76
2017	9	172	0	116
2018	8	107	1	239
2019	5	149	0	242
2020	4	161	1	234
2021	3	62	0	210
2022	5	107	11	202
2023	9	72	0	175
2024	4	29	0	206
2025	3	65	0	314
2026	2	—	2	—

What is it indicated for?

Indicated for use in Rotator Cuff Repair

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K020948 · printed Nov 5, 2026

Cite this page

510(k) Report. “K020948: Smith & Nephew Suretac - Expanded Indications II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020948

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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