510(k) · Cleared

Cleared

Pontis Sutures and Suture Anchors with Optional Crimps

K101126510(k) TraditionalCleared Dec 2, 2010224-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, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Dec 2, 2010 as substantially equivalent to K081060 (Core Essence Orthopaedics, LLC, 2008) and 4 other predicates after a 224-day review. Its family tree reaches back 4 generations to 1996. 3 later devices descend from it.

Decided: Dec 2, 2010
Review: 224 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 5

Its longest line of descent runs back 4 generations to K961555 (1996). 28 ancestors in all, the oldest K844068 (1985). 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
3 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
2 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
1 generation backK071520 Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007
This deviceK101126 Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010
Descendant · cites it directly · 1 of its ownK140127 Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014
Descendant · 2 generations on · 0 of its ownK143582 Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide…Resorba Medical GmbH · 2015
Descendant · cites it directly · 0 of its ownK141711 Pontis 3MM Suture Anchors with Ultra-High Molecular Weight…Pontis Orthopaeeics, LLC · 2014

Most influential descendants

Showing 3 of 3 · See all

K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014 · cites it directly1descendant
K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH · 2015 · 2 generations on0descendants
K141711Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis…Pontis Orthopaeeics, LLC · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K961555	Acufex Tag Bioabsorbable Anchors	Acufex Microsurgical, Inc.	1996	—
−3	K031685	Tag Rod Bioraptor Suture Anchor 7209317, 7209318	Smith & Nephew, Inc.	2003	5
−2	K053344	Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…	Smith & Nephew, Inc.	2006	—
−1	K071520	Renovo Suture Anchors, Models 100-2001 Thru 100-5502X	Core Essence Orthopaedics, LLC	2007	—
0 (this device)	K101126	Pontis Sutures and Suture Anchors with Optional Crimps	Core Essence Orthopaedics, Inc.	2010	—
+1	K140127	Ferrofibre Stainless Steel Suture with Crimp	Pontis Orthopaedics, LLC	2014	—
+2	K143582	Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel	Resorba Medical GmbH	2015	—
+1	K141711	Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene…	Pontis Orthopaeeics, LLC	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1987	1	0
1990	2	0
1993	1	0
1994	2	0
1995	2	0
1996	4	0
1997	1	0
1998	3	0
1999	2	0
2001	1	0
2002	1	0
2003	1	0
2004	1	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	2	0
2015	1	0

FIG. 1 — Lineage of K101126, 1996–2015Source: 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? (5)

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
*	K081060	Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5 Summary page 2 …operational principals, and indications to other metallic sutures or cables secured with a crimp, including the Core Essence PONTiS TM ferroFibre stainless steel suture (K081060), the Pioneer Surgical SDB Cerclage System (K9926 16), the Ortheon Medical Tenofix tendon repair devices (K023594). The Substant…	Core Essence Orthopaedics, LLC	2008	—
*	K992616	SDB Cerclage System Summary page 2 …allic sutures or cables secured with a crimp, including the Core Essence PONTiS TM ferroFibre stainless steel suture (K081060), the Pioneer Surgical SDB Cerclage System (K9926 16), the Ortheon Medical Tenofix tendon repair devices (K023594). The Substantial equivalence of the PONTiSr" 3.0mm suture anchors…	Pioneer Surgical Technology	1999	—
*	K023594	Teno Fix Summary page 2 …re Essence PONTiS TM ferroFibre stainless steel suture (K081060), the Pioneer Surgical SDB Cerclage System (K9926 16), the Ortheon Medical Tenofix tendon repair devices (K023594). The Substantial equivalence of the PONTiSr" 3.0mm suture anchors are based on the equivalence in intended use, materials, oper…	Ortheon Medical, LLC	2003	—
*	K071520	Renovo Suture Anchors, Models 100-2001 Thru 100-5502X Summary page 2 …e equivalence in intended use, materials, operational principals, and indications to reNOVO~~" and other suture anchors including the Core Essence Orthopaedics reNOVOTM (K07 1520) and the J&J DePuy Mitek Micro Anchor (K96251 1). Brief Description of the Device, Sutures with Crimp Collars This premarket…	Core Essence Orthopaedics, LLC	2007	—
*	K962511	Mitek Micro Anchor Summary page 2 …ional principals, and indications to reNOVO~~" and other suture anchors including the Core Essence Orthopaedics reNOVOTM (K07 1520) and the J&J DePuy Mitek Micro Anchor (K96251 1). Brief Description of the Device, Sutures with Crimp Collars This premarket notification covers line extensions for the PONT…	Mitek Products	1996	—

Also cleared against K081060: 2 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K140127	Ferrofibre Stainless Steel Suture with Crimp	Pontis Orthopaedics, LLC	2014	1
K141711	Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis…	Pontis Orthopaeeics, LLC	2014	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 14 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
3 of the 28 ancestors have a recall of any class.
Of its descendants, K140127 (Pontis Orthopaedics, LLC, 2014) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K081060.

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. 2010, 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?

PONTiSTM Sutures with Optional Crimps are indicated to secure soft tissue to soft tissue reattachment in the hand:

* Collateral Ligaments around the PIP, DIP and MCP Joints

* Flexor and Extensor Tendons

PONTiSrM Suture Anchors with Optional Crimps are indicated to secure soft tissue to bone reattachment in the hand:

" Collateral Ligaments around the PIP, DIP and MCP Joints

* Flexor and Extensor Tendons

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101126 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101126: Pontis Sutures and Suture Anchors with Optional Crimps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101126

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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