510(k) · Cleared

Cleared

Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor W/Orthocord, Healix Transtend

K102298510(k) TraditionalCleared Jan 7, 2011147-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

Depuy Mitek, A Johnson & Johnson Company · HWC Screw, Fixation, Bone

Cleared on Jan 7, 2011 as substantially equivalent to K100012 (Depuy Mitek, A Johnson & Johnson Company, 2010) and 7 other predicates after a 147-day review. Its family tree reaches back 9 generations to 1997. 15 later devices descend from it.

Decided: Jan 7, 2011
Review: 147 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 8

Its longest line of descent runs back 9 generations to K971358 (1997). 53 ancestors in all, the oldest K930893 (1993). 15 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 9 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
5 generations between
3 generations backK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
2 generations backK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
1 generation backK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
This deviceK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
Descendant · cites it directly · 6 of its ownK211002 Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · Recalled
Descendant · cites it directly · 6 of its ownK103712 Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011
Descendant · 2 generations on · 3 of its ownK222091 Grappler Suture Anchor SystemParagon 28, Inc. · 2022
Descendant · 2 generations on · 2 of its ownK223589 Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2023
Descendant · 2 generations on · 1 of its ownK240594 Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2024

Show all 9 generations

Root · 9 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
8 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
7 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
6 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
5 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
4 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
3 generations backK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
2 generations backK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
1 generation backK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
This deviceK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2011high 2 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 15 · See all

K211002Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · cites it directly6descendants
K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011 · cites it directly6descendants
K222091Grappler Suture Anchor SystemParagon 28, Inc. · 2022 · 2 generations on3descendants
K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2023 · 2 generations on2descendants
K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2024 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K971358	Bio-Interference Screw, 7 MM, 8 MM, 9 MM	Arthrex, Inc.	1997	—
−8	K990454	Bio-Interference Screw	Innovasive Devices, Inc.	1999	—
−7	K993975	Absolute Absorbable Interference Screw	Innovasive Devices, Inc.	1999	—
−6	K013572	Mitek Biocryl Interference Screws	Mitek Products	2002	—
−5	K032717	Biocryl Rapide Interference Screw	Mitek Worldwide	2004	—
−4	K060830	Milagro Interference Screw	Depuy Mitek, A Johnson & Johnson Company	2006	—
−3	K073412	Gryphon BR and Healix BR Anchors	Depuy Mitek, A Johnson & Johnson Company	2008	1
−2	K090124	Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model…	Depuy Mitek, A Johnson & Johnson Company	2009	2
−1	K100012	Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon…	Depuy Mitek, A Johnson & Johnson Company	2010	—
0 (this device)	K102298	Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend…	Depuy Mitek, A Johnson & Johnson Company	2011	—
+1	K211002	Grappler Suture Anchor System	Paragon 28, Inc.	2021	1
+1	K103712	Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord	Depuy Mitek, A Johnson & Johnson Company	2011	—
+2	K222091	Grappler Suture Anchor System	Paragon 28, Inc.	2022	—
+2	K223589	Grappler Suture Anchor R3FLEX IOL System	Paragon 28, Inc.	2023	—
+2	K240594	Grappler Suture Anchor R3FLEX IOL System	Paragon 28, Inc.	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1994	1	0
1995	1	0
1996	2	0
1997	1	0
1998	2	0
2000	2	0
2001	6	0
2002	2	0
2003	1	0
2004	9	0
2005	3	0
2006	6	0
2007	4	0
2008	2	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2013	2	0
2014	2	0
2018	1	0
2021	1	0
2022	1	0
2023	2	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K102298, 1997–2026Source: 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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 14 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? (8)

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
*	K100012	Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS… Summary page 1 …Proprietary Name: TranisTend Anchors Substantial The proposed TransTend Anchors are substantially equivalent to: Equivalence K1000 12 Gryphon Br - Hip (March 10, 2010) K090 124 Gryphon P BR Anchor (March 11, 2009) K0734…	Depuy Mitek, A Johnson & Johnson Company	2010	—
*	K090124	Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814 Summary page 1 …The proposed TransTend Anchors are substantially equivalent to: Equivalence K1000 12 Gryphon Br - Hip (March 10, 2010) K090 124 Gryphon P BR Anchor (March 11, 2009) K073412 Gryphon BR / Healix BR Anchors (January 17, 2008)…	Depuy Mitek, A Johnson & Johnson Company	2009	2
*	K073412	Gryphon BR and Healix BR Anchors Summary page 1 …o: Equivalence K1000 12 Gryphon Br - Hip (March 10, 2010) K090 124 Gryphon P BR Anchor (March 11, 2009) K073412 Gryphon BR / Healix BR Anchors (January 17, 2008) *K082282 Healix Ti Anchor (November 7, 2008)…	Depuy Mitek, A Johnson & Johnson Company	2008	1
*	K082282	Healix TI Anchor Summary page 1 …K090 124 Gryphon P BR Anchor (March 11, 2009) K073412 Gryphon BR / Healix BR Anchors (January 17, 2008) *K082282 Healix Ti Anchor (November 7, 2008) K07 148 1 Heal ix Peek Anchor (August 9, 2007)…	Depuy Mitek, A Johnson & Johnson Co.	2008	—
*	K071481	Healix Anchor Summary page 1 …K073412 Gryphon BR / Healix BR Anchors (January 17, 2008) K082282 Healix Ti Anchor (November 7, 2008) K07 148 1 Heal ix Peek Anchor (August 9, 2007) K082810 Arthrex BioComposite Corkscrew Anchor (January 23, 2009)…	Depuy Mitek, A Johnson & Johnson Company	2007	—
*	K082810	Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak… Summary page 1 …2008) K082282 Healix Ti Anchor (November 7, 2008) K07 148 1 Heal ix Peek Anchor (August 9, 2007) K082810 Arthrex BioComposite Corkscrew Anchor (January 23, 2009) K08 1598 KFX Suture lock Nail Bone Anchor (July 3,…	Arthrex, Inc.	2009	—
*	K081598	Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200) Fiberforce Suture Summary page 1 …K07 148 1 Heal ix Peek Anchor (August 9, 2007) K082810 Arthrex BioComposite Corkscrew Anchor (January 23, 2009) K08 1598 KFX Suture lock Nail Bone Anchor (July 3, 2008) K020159 Twin Fix Ti Quick T 3.5 rum Fixation System ( March…	Kfx Medical	2008	—
*	K020159	Smith & Nephew Twinfix TI Quick T Summary page 1 …K082810 Arthrex BioComposite Corkscrew Anchor (January 23, 2009) K08 1598 KFX Suture lock Nail Bone Anchor (July 3, 2008) K020159 Twin Fix Ti Quick T 3.5 rum Fixation System ( March 26, 2010) Device These devices carry an FDA product code HWC, a…	Smith & Nephew, Inc.	2002	—

Also cleared against K100012: 7 other devices →

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K211002	Grappler Suture Anchor System	Paragon 28, Inc.	2021	6
K103712	Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord	Depuy Mitek, A Johnson & Johnson Company	2011	6
K243790	GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor	Depuy Mitek	2025	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 5 companies; a new generation was cleared every 1.6 years on median.
13 of the 53 ancestors have a recall of any class.
Of its descendants, K211002 (Paragon 28, Inc., 2021) has gone furthest, with 6 descendants of its own.
7 other devices also cite its predicate K100012.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	35	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

The TransTend Anchor is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows: Shoulder — Rotator Cuff (BR, PEEK, Titanium); Partial Thickness Rotator Cuff (BR, PEEK, Titanium); Biceps Tenodesis (PEEK, Titanium); Acromio-Clavicular Separation (PEEK, Titanium); Deltoid Repair (PEEK, Titanium) Foot/Ankle — Lateral Stabilization (PEEK, Titanium); Medial Stabilization (PEEK, Titanium); Mid-foot…

Read the full statement (120 words)

The TransTend Anchor is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows:

Shoulder — Rotator Cuff (BR, PEEK, Titanium); Partial Thickness Rotator Cuff (BR, PEEK, Titanium); Biceps Tenodesis (PEEK, Titanium); Acromio-Clavicular Separation (PEEK, Titanium); Deltoid Repair (PEEK, Titanium)

Foot/Ankle — Lateral Stabilization (PEEK, Titanium); Medial Stabilization (PEEK, Titanium); Mid-foot Reconstruction (PEEK, Titanium); Hallux Valgus Repair (BR, Titanium); Metatarsal Ligament/Tendon Repairs (PEEK, Titanium)

Knee — Medial Collateral Ligament Repair (PEEK, Titanium); Lateral Collateral Ligament Repair (PEEK, Titanium); Posterior Oblique Ligament Repair (PEEK, Titanium); Iliotibial Band Tenodesis (PEEK, Titanium)

Elbow — Lateral Epicondylitis Repair (PEEK, Titanium)

Wrist — Scapholunate Ligament Reconstruction (PEEK, Titanium)

Hip — Capsular Repair (PEEK, Titanium); Acetabular Labral Repair (PEEK, Titanium)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102298 · printed Nov 4, 2026

Cite this page

510(k) Report. “K102298: Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor W/Orthocord, Healix Transtend.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102298

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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