510(k) · Cleared

Recalled · Class II · 2013

Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)

K111471510(k) SpecialCleared Jun 10, 201114-day reviewClass II21 CFR 888.3040Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medshape Solutions, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Jun 10, 2011 as substantially equivalent to K101808 (Medshape Solutions, 2010) and 2 other predicates after a 14-day review. Its family tree reaches back 7 generations to 1996. 1 later device descends from it. It has been recalled once.

Decided: Jun 10, 2011
Review: 14 days
Class: Class II
Product code: MBI
Recalls: 1
Predicates: 3

Its longest line of descent runs back 7 generations to K961555 (1996). 25 ancestors in all, the oldest K895711 (1990). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 7 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
6 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
5 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
4 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
3 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
2 generations backK083226 Smith & Nephew Peek Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
1 generation backK091093 Parcus Ppek CF Interference ScrewParcus Medical, LLC · 2009
This deviceK111471 Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX…Medshape Solutions, Inc. · 2011
Descendant · cites it directly · 0 of its ownK132783 Exoshape Duo Soft Tissue FastenerMedShape, Inc. · 2013

Most influential descendants

Showing 1 of 1 · See all

K132783Exoshape Duo Soft Tissue FastenerMedShape, Inc. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K961555	Acufex Tag Bioabsorbable Anchors	Acufex Microsurgical, Inc.	1996	—
−6	K031685	Tag Rod Bioraptor Suture Anchor 7209317, 7209318	Smith & Nephew, Inc.	2003	5
−5	K053344	Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…	Smith & Nephew, Inc.	2006	—
−4	K061154	Kinsa Suture Anchor	Smith & Nephew, Inc.	2006	—
−3	K071586	Bioraptor 2.3 PK Suture Anchor	Smith & Nephew Inc., Endoscopy Division	2007	1
−2	K083226	Smith & Nephew Peek Interference Screw	Smith & Nephew Endoscopy, Inc.	2009	—
−1	K091093	Parcus Ppek CF Interference Screw	Parcus Medical, LLC	2009	—
0 (this device)	K111471	Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)	Medshape Solutions, Inc.	2011	—
+1	K132783	Exoshape Duo Soft Tissue Fastener	MedShape, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	2	0
1993	2	0
1994	1	0
1995	1	0
1996	1	0
1998	2	0
1999	1	0
2000	1	0
2003	1	0
2004	1	0
2005	1	0
2006	1	0
2007	1	0
2009	1	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K111471, 1996–2013Source: 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? (3)

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
*	K101808	Shapeloc-CL (Cruciate Ligament) Soft Tissie Fastner, Shapeloc-ST (Tenodesis) Soft Tissue… Summary page 1 …Non-degradable, Soft Tissue HWC/MBI 21 CFR 588.3040 E. Predicate Device(s): MSS, ShapeLoc Interference Fixation Device, K1 01808 Parcus Medical PEEK CIF Interference Screw, K091 093 Arthrex@® Interference Screw, K062466 F. Labeling an…	Medshape Solutions	2010	—
*	K091093	Parcus Ppek CF Interference Screw Summary page 1 …HWC/MBI 21 CFR 588.3040 E. Predicate Device(s): MSS, ShapeLoc Interference Fixation Device, K1 01808 Parcus Medical PEEK CIF Interference Screw, K091 093 Arthrex@® Interference Screw, K062466 F. Labeling and Intended Use: No substantive changes to the labelin…	Parcus Medical, LLC	2009	—
*	K062466	Arthrex Interference Screw Summary page 1 …ce(s): MSS, ShapeLoc Interference Fixation Device, K1 01808 Parcus Medical PEEK CIF Interference Screw, K091 093 Arthrex@® Interference Screw, K062466 F. Labeling and Intended Use: No substantive changes to the labeling or Instructions for Use have been ma…	Arthrex, Inc.	2006	—

Also cleared against K101808: 2 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
K132783	Exoshape Duo Soft Tissue Fastener	MedShape, Inc.	2013	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 4, 2013	Class II	Z-1276-2013	Error in labeling	Expiration date on the patient label and date on the product carton were not the same.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
4 of the 25 ancestors have a recall of any class.
Of its descendants, K132783 (MedShape, Inc., 2013) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K101808.

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. 2011, 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 MedShape Solutions, Inc., ExoShape TM -XL Interference Fixation Device is intended for fixation of soft tissue to bone in the following procedures: Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hailux Valgus Reconstruction, Mid-foot…

Read the full statement (130 words)

The MedShape Solutions, Inc., ExoShape TM -XL Interference Fixation Device is intended

for fixation of soft tissue to bone in the following procedures:

Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps

Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,

Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hailux

Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament

Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and

Tendon Transfers

Knee: Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral

Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique

Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament

Reconstruction, Radial Collateral Ligament Reconstruction,

Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty),

Carpal Ligament Reconstructions and Repairs and Tendon Transfers

Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament

Reconstruction

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111471 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111471: Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111471

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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