510(k) · Cleared

Recalled · Class II · 2015

Accin Total Knee System

K081127510(k) TraditionalCleared Oct 17, 2008179-day reviewClass II21 CFR 888.3560Recalls 1

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

Accelerated Innovation, LLC · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Oct 17, 2008 as substantially equivalent to K962152 (Osteonics Corp., 1996) and 2 other predicates after a 179-day review. Its family tree reaches back 1 generation to 1996. 25 later devices descend from it. It has been recalled once.

Decided: Oct 17, 2008
Review: 179 days
Class: Class II
Product code: JWH
Recalls: 1
Predicates: 3

Its longest line of descent runs back 1 generation to K962152 (1996). 3 ancestors in all. 25 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK962152 Osteonics Scorpio Posteriorly Stabilized Total Knee SystemOsteonics Corp. · 1996 · Recalled
This deviceK081127 Accin Total Knee SystemAccelerated Innovation, LLC · 2008
Descendant · cites it directly · 15 of its ownK141635 Arthrex Ibalance Tka SystemArthrex, Inc. · 2014
Descendant · 2 generations on · 10 of its ownK151256 Arthrex BioSync® Bone WedgeArthex, Inc. · 2015 · Recalled
Descendant · 3 generations on · 7 of its ownK192645 Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2019
Descendant · 3 generations on · 6 of its ownK193414 Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020
Descendant · 4 generations on · 5 of its ownK203445 Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2009high 4 (2024) · low 0 (2011)2026

Most influential descendants

Showing 5 of 25 · See all

K141635Arthrex Ibalance Tka SystemArthrex, Inc. · 2014 · cites it directly15descendants
K151256Arthrex BioSync® Bone WedgeArthex, Inc. · 2015 · 2 generations on10descendants
K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2019 · 3 generations on7descendants
K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020 · 3 generations on6descendants
K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962152	Osteonics Scorpio Posteriorly Stabilized Total Knee System	Osteonics Corp.	1996	13
0 (this device)	K081127	Accin Total Knee System	Accelerated Innovation, LLC	2008	—
+1	K141635	Arthrex Ibalance Tka System	Arthrex, Inc.	2014	—
+2	K151256	Arthrex BioSync® Bone Wedge	Arthex, Inc.	2015	6
+3	K192645	Trigon™ Ti Stand-Alone Wedge Fixation System	Nvision Biomedical Technologies, Inc.	2019	—
+3	K193414	Trigon HA Stand-Alone Wedge Fixation System	Nvision Biomedical Technologies, Inc.	2020	—
+4	K203445	Trigon HA Stand-Alone Wedge Fixation System	Nvision Biomedical Technologies, Inc.	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2013	1	0
2014	3	0
2015	3	0
2016	1	0
2017	1	0
2019	1	0
2020	2	0
2022	2	0
2023	2	0
2024	4	0
2025	3	0

FIG. 1 — Lineage of K081127, 1996–2025Source: 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 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

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
*	K962152	Osteonics Scorpio Posteriorly Stabilized Total Knee System Summary page 1 …Cemented, Polymer/Metal/Polymer - Class 11 (21 CFR 888.3560) Predicate Device: -Osteonics" Scorpio Posteriorly Stabilized Total Knee System (K962152) * Osteonicsc Scorpio Posterior Cruciate Retaining Total Knee System (K(974556) • Z…	Osteonics Corp.	1996	13
*	K974556	Osteonics Scorpio Posterior Cruciate Retaining Total Knee System Summary page 1 …-Osteonics" Scorpio Posteriorly Stabilized Total Knee System (K962152) * Osteonicsc Scorpio Posterior Cruciate Retaining Total Knee System (K(974556) • Zimmer Nex~en' Complete Knee Solution Legacy® Posterior Stabilized (LPS); LPS-Fl…	Osteonics Corp.	1998	7
*	K991581	Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing… Summary page 1 …• Zimmer Nex~en' Complete Knee Solution Legacy® Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface Components (K991581) Device Description: The AccintM total knee system consists of a series of cobalt chrome femoral compo…	Zimmer, Inc.	1999	7
†	K073120	Accin Patellofemoral System	Accelerated Innovation, LLC	2008	—

Also cleared against K962152: 9 other devices →

What descends from it? (25)

See all 25

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

Number	Device	Applicant	Decided	Descendants
K141635	Arthrex Ibalance Tka System	Arthrex, Inc.	2014	15
K133854	Arthrex Ibalance Tka System	Arthrex, Inc.	2014	4
K152252	Arthrex iBalance TKA System	Arthrex, Inc.	2015	2
K152382	Arthrex iBalance TKA System	Arthrex, Inc.	2015	2
K143047	Arthrex iBalance Patella Implant, Dome	Arthrex, Inc.	2014	2
K153586	Arthrex iBalance TKA System	Arthrex, Inc.	2016	1
K133342	Arthrex Ibalance Tka System	Arthrex, Inc.	2013	0
K101032	Cardo Medical Femoral Cement Restrictor, Model 503-MCRX	Cardo Medical, Inc.	2010	0
K092803	Cardo Medical Align 360 Medialized Patella Component	Cardo Medical Corp.	2009	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 17, 2015	Class II	Z-1195-2016	Nonconforming Material/Component	Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.

No ancestor or descendant has a Class I recall.

What does this lineage say?

3 of the 3 ancestors have a recall of any class.
Of its descendants, K141635 (Arthrex, Inc., 2014) has gone furthest, with 15 descendants of its own.
9 other devices also cite its predicate K962152.

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. 2008, this device’s year, is highlighted.

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	—

What is it indicated for?

The ACCIN Total Knee System components are for use in total knee arthroplasty as a result of: * Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; * Post-traumatic loss of knee joint configuration and function * Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; * Revisions of previous…

Read the full statement (110 words)

The ACCIN Total Knee System components are for use in total knee arthroplasty as a result of:

* Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis;

* Post-traumatic loss of knee joint configuration and function

* Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;

* Revisions of previous unsuccessful knee replacement or other procedure.

Additional indications for posteriorly stabilized components:

- Ligamentous instability requiring implant bearing surfaces with increased constraint;

• Absent or non-functioning posterior cruciate ligament.

These devices are single use only and are intended for implantation with bone cement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081127 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081127: Accin Total 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/K081127

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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