510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Unity Toatal Knee System

K113060510(k) TraditionalCleared Sep 10, 2012332-day reviewClass II21 CFR 888.3560Recalls 3

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

Corin USA · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Sep 10, 2012 as substantially equivalent to K031729 (Howmedica Osteonics Corp., 2003) and 7 other predicates after a 332-day review. Its family tree reaches back 2 generations to 1992. 8 later devices descend from it. It has been recalled 3 times.

Decided
Sep 10, 2012
Review
332 days
Class
Class II
Product code
JWH
Recalls
3
Predicates
8

Its longest line of descent runs back 2 generations to K915192 (1992). 13 ancestors in all. 8 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 2 other ancestors2004: 2 other ancestors2003: 1 other ancestor1998: 2 other ancestors1996: 2 other ancestors1993: 1 other ancestor1992: 1 other ancestor2024: 3 descendants cleared2017: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2026: 2 descendants clearedK915192 · 7000 Series Modular Tibial Components · Osteonics Corp. · 1992K994128 · Scorpio Total Stablizer (TS) Total Knee System · Howmedica Osteonics Corp. · 2000 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 4 other ancestors 1 generation forward: 6 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K994128 · Scorpio Total Stablizer (TS) Total Knee System · Howmedica Osteonics Corp. · 2000 · recalledK915192 · 7000 Series Modular Tibial Components · Osteonics Corp. · 19920
  1. Root · 2 generations backK915192 7000 Series Modular Tibial ComponentsOsteonics Corp. · 1992
  2. 1 generation backK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
  3. This deviceK113060 Unity Toatal Knee SystemCorin USA · 2012
  4. Descendant · cites it directly · 2 of its ownK173884 Unity Total Knee SystemCorin U.S.A. Limited · 2018
  5. Descendant · 2 generations on · 1 of its ownK234044 ACS® LD FB Knee SystemImplantcast GmbH · 2024
  6. Descendant · cites it directly · 1 of its ownK183533 Unity Total Knee SystemCorin U.S.A. Limited · 2019
  7. Descendant · cites it directly · 0 of its ownK261275 Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd. · 2026
  8. Descendant · 3 generations on · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2017: 12018: 12019: 12024: 32026: 2
2017high 3 (2024) · low 0 (2020)2026

Most influential descendants

Showing 5 of 8 · See all
  • K173884Unity Total Knee SystemCorin U.S.A. Limited · 2018 · cites it directly2descendants
  • K234044ACS® LD FB Knee SystemImplantcast GmbH · 2024 · 2 generations on1descendant
  • K183533Unity Total Knee SystemCorin U.S.A. Limited · 2019 · cites it directly1descendant
  • K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd. · 2026 · cites it directly0descendants
  • K260037implantcast Packaging System UpdateImplantcast GmbH · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K9151927000 Series Modular Tibial ComponentsOsteonics Corp.1992—
−1K994128Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp.20008
0 (this device)K113060Unity Toatal Knee SystemCorin USA2012—
+1K173884Unity Total Knee SystemCorin U.S.A. Limited2018—
+2K234044ACS® LD FB Knee SystemImplantcast GmbH2024—
+1K183533Unity Total Knee SystemCorin U.S.A. Limited2019—
+1K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.2026—
+3K260037implantcast Packaging System UpdateImplantcast GmbH2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199310
199620
199820
200310
200420
200520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
201910
202430
202620
FIG. 1 — Lineage of K113060, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K031729Triathlon Posteriorly Stabilized (PS) Total Knee System
Summary page 1
…metal/polymer semi- constrained cemented prosthesis (21CFR888.3560) 7. Legally Marketed Devices to which Substantial Equivalence is claimed: Triathlon PS TKA System (KK031729) Triathlon CR TKA System (K040267) Triathlon CR sz 1 Tibial Insert (IK042883) Triathlon PS sz 1 Tibial Insert (K050539) Scorpio C…
Howmedica Osteonics Corp.20033
*K040267Triathlon Cruciate Retaining (CR) Total Knee
Summary page 1
…emented prosthesis (21CFR888.3560) 7. Legally Marketed Devices to which Substantial Equivalence is claimed: Triathlon PS TKA System (KK031729) Triathlon CR TKA System (K040267) Triathlon CR sz 1 Tibial Insert (IK042883) Triathlon PS sz 1 Tibial Insert (K050539) Scorpio CR TKA System (K974556) Scorpio PS…
Howmedica Osteonics Corp.20041
*K042883Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert
Summary page 1
…lly Marketed Devices to which Substantial Equivalence is claimed: Triathlon PS TKA System (KK031729) Triathlon CR TKA System (K040267) Triathlon CR sz 1 Tibial Insert (IK042883) Triathlon PS sz 1 Tibial Insert (K050539) Scorpio CR TKA System (K974556) Scorpio PS TKA System (1K962152) Scorpio NRG System (K…
Howmedica Osteonics Corp.2004—
*K050539Size 1 Triathlon Posterior Stabilized (PS) Tibial Insert
Summary page 1
…Equivalence is claimed: Triathlon PS TKA System (KK031729) Triathlon CR TKA System (K040267) Triathlon CR sz 1 Tibial Insert (IK042883) Triathlon PS sz 1 Tibial Insert (K050539) Scorpio CR TKA System (K974556) Scorpio PS TKA System (1K962152) Scorpio NRG System (K042343) Scorpio TS (K994128) 8. Device D…
Howmedica Osteonics Corp.2005—
*K974556Osteonics Scorpio Posterior Cruciate Retaining Total Knee System
Summary page 1
…on PS TKA System (KK031729) Triathlon CR TKA System (K040267) Triathlon CR sz 1 Tibial Insert (IK042883) Triathlon PS sz 1 Tibial Insert (K050539) Scorpio CR TKA System (K974556) Scorpio PS TKA System (1K962152) Scorpio NRG System (K042343) Scorpio TS (K994128) 8. Device Description: The Corin Unity Kne…
Osteonics Corp.19987
*K962152Osteonics Scorpio Posteriorly Stabilized Total Knee System
Summary page 1
…hlon CR TKA System (K040267) Triathlon CR sz 1 Tibial Insert (IK042883) Triathlon PS sz 1 Tibial Insert (K050539) Scorpio CR TKA System (K974556) Scorpio PS TKA System (1K962152) Scorpio NRG System (K042343) Scorpio TS (K994128) 8. Device Description: The Corin Unity Knee System is a fixed bearing total…
Osteonics Corp.199613
*K042343Scorpio NRG Knee System
Summary page 1
…Triathlon CR sz 1 Tibial Insert (IK042883) Triathlon PS sz 1 Tibial Insert (K050539) Scorpio CR TKA System (K974556) Scorpio PS TKA System (1K962152) Scorpio NRG System (K042343) Scorpio TS (K994128) 8. Device Description: The Corin Unity Knee System is a fixed bearing total knee replacement system that…
Howmedica Osteonics Corp.20051
*K994128Scorpio Total Stablizer (TS) Total Knee System
Summary page 1
…al Insert (IK042883) Triathlon PS sz 1 Tibial Insert (K050539) Scorpio CR TKA System (K974556) Scorpio PS TKA System (1K962152) Scorpio NRG System (K042343) Scorpio TS (K994128) 8. Device Description: The Corin Unity Knee System is a fixed bearing total knee replacement system that consists of a femora…
Howmedica Osteonics Corp.20008

Also cleared against K031729: 14 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K173884Unity Total Knee SystemCorin U.S.A. Limited20182
K183533Unity Total Knee SystemCorin U.S.A. Limited20191
K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.20260
K241570Unity Total Knee SystemCorin U.S.A. Limited20240
K240875Unity Knee PS-C Tibial InsertCorin U.S.A. Limited20240
K170808Unity Total Knee SystemCorin U.S.A. Limited20170

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 13, 2023Class IIZ-0213-2024Process change controlPotential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
Oct 13, 2023Class IIZ-0214-2024Process change controlPotential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
Oct 31, 2022Class IIZ-0273-2023Under Investigation by firmThe internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
  • 8 of the 13 ancestors have a recall of any class.
  • Of its descendants, K173884 (Corin U.S.A. Limited, 2018) has gone furthest, with 2 descendants of its own.
  • 14 other devices also cite its predicate K031729.

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. 2012, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

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

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
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

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

What is it indicated for?

The Unity Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components. General total knee arthroplasty indications include: Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or…

Read the full statement (162 words)

The Unity Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.

General total knee arthroplasty indications include:

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

Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is adequate

Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques

The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-postetior constraint and absent or non-functioning posterior cruciate ligament

The Unity Total Knee System is indicated for cemented, single use only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K031729

14 other devices cite the same predicate.

  • K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics · 2026
  • K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
  • K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd. · 2018
  • K173849Triathlon Total Knee SystemStryker Orthopaedics · 20183 recalls
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 20171 recall
  • K140222Saiph Knee SystemMatortho · 2014

More from Corin USA

70 FDA decisions under this applicant name. See the company

  • K203751OMNIVision systemCorin USA · 2021
  • K202805Optimized Positioning System (OPS) InsightCorin USA · 2020
  • K193545Corin Optimized Positioning System (OPS) FemoralCorin USA · 2020
  • P050016/S012Cormet Hip Resurfacing SystemCorin USA · 2020
  • K193042Optimized Positioning System (OPS) ReViewCorin USA · 2020

Recent decisions in JWH

The JWH category page

  • K262057GMK ExtensionMedacta International SA · 2026
  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026

https://510kreport.com/device/K113060 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113060: Unity Toatal 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/K113060

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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