510(k) · Cleared

Cleared

Ascent Knee System

K011219510(k) SpecialCleared May 18, 200128-day reviewClass II21 CFR 888.3560

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

Biomet, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on May 18, 2001 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 60 later devices descend from it.

Decided: May 18, 2001
Review: 28 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 0

60 later devices descend from it, 1 citing it directly.

This deviceK011219 Ascent Knee SystemBiomet, Inc. · 2001
Descendant · cites it directly · 59 of its ownK072785 Twinfix FT PKSmith & Nephew Inc., Endoscopy Division · 2007
Descendant · 2 generations on · 40 of its ownK110545 Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor…Smith & Nephew, Inc. · 2011
Descendant · 3 generations on · 25 of its ownK133671 Iconix All Suture AnchorsStryker Corp. · 2014
Descendant · 2 generations on · 19 of its ownK093228 Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc. · 2009
Descendant · 3 generations on · 17 of its ownK100159 Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · Recalled

Showing 5 of 60 descendants. See all descendants

Descendants cleared per year

2007high 9 (2023) · low 0 (2008)2026

Most influential descendants

Showing 5 of 60 · See all

K072785Twinfix FT PKSmith & Nephew Inc., Endoscopy Division · 2007 · cites it directly59descendants
K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc. · 2011 · 2 generations on40descendants
K133671Iconix All Suture AnchorsStryker Corp. · 2014 · 3 generations on25descendants
K093228Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc. · 2009 · 2 generations on19descendants
K100159Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · 3 generations on17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011219	Ascent Knee System	Biomet, Inc.	2001	—
+1	K072785	Twinfix FT PK	Smith & Nephew Inc., Endoscopy Division	2007	—
+2	K110545	Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)	Smith & Nephew, Inc.	2011	—
+3	K133671	Iconix All Suture Anchors	Stryker Corp.	2014	—
+2	K093228	Smith & Nephew Twinfix Ultra PK Suture Anchor	Smith & Nephew, Inc.	2009	—
+3	K100159	Smith and Nephew Twinfix Ultra TI Suture Anchor	Smith & Nephew Inc., Endoscopy Div.	2010	4

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2009	2	0
2010	4	0
2011	1	0
2012	2	0
2013	1	0
2014	2	0
2015	4	0
2016	2	0
2017	4	0
2018	1	0
2019	1	0
2020	4	0
2021	1	0
2022	5	0
2023	9	0
2024	5	0
2025	8	0
2026	3	0

FIG. 1 — Lineage of K011219, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JWH? 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 JWH device

#1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (60)

See all 60

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

Number	Device	Applicant	Decided	Descendants
K072785	Twinfix FT PK	Smith & Nephew Inc., Endoscopy Division	2007	59

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?

Of its descendants, K072785 (Smith & Nephew Inc., Endoscopy Division, 2007) has gone furthest, with 59 descendants of its own.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JWH

20in 2025

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

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

Recalls per year · JWH

2in 2025

2007high 109 (2009) · low 2 (2020)2026

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

Adverse event reports per year · JWH

9,306in 2025

2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, 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	18	74	14	1,305
2008	17	81	10	1,483
2009	11	168	109	1,870
2010	19	85	32	3,286
2011	25	87	27	5,133
2012	33	85	85	5,203
2013	31	128	31	6,135
2014	33	98	13	6,722
2015	27	87	11	6,881
2016	18	88	17	7,586
2017	25	118	61	12,263
2018	25	90	14	14,071
2019	28	133	5	14,987
2020	22	59	2	12,592
2021	24	61	8	9,408
2022	17	56	12	8,364
2023	20	57	67	8,947
2024	19	89	7	10,828
2025	20	55	2	9,306
2026	12	63	4	—

https://510kreport.com/device/K011219 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011219: Ascent Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011219

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026