510(k) Report

510(k) · Cleared

Cleared

All Poly Tibial Component

K152430510(k) TraditionalCleared Apr 12, 2016230-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

United Orthopedic Corporation · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Apr 12, 2016 as substantially equivalent to K974556 (Osteonics Corp., 1998) and 4 other predicates after a 230-day review. Its family tree reaches back 6 generations to 1992.

Decided
Apr 12, 2016
Review
230 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
5

Its longest line of descent runs back 6 generations to K915132 (1992). 41 ancestors in all, the oldest P830055 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2014: 1 other ancestor2006: 1 other ancestor1998: 1 other ancestor1996: 3 other ancestors2011: 1 other ancestor2009: 1 other ancestor2008: 1 other ancestor2005: 3 other ancestors2002: 1 other ancestor1999: 1 other ancestor2007: 2 other ancestors2004: 1 other ancestor2001: 3 other ancestors2000: 3 other ancestors1995: 5 other ancestors1993: 1 other ancestor1991: 1 other ancestor1987: 1 other ancestor1985: 1 other ancestor2003: 1 other ancestor1997: 1 other ancestor1994: 1 other ancestorK915132 · MCK Maximum Congruent Knee) Knee System · Biomet, Inc. · 1992 · recalledK023546 · Maxim Accel Knee System · Biomet, Inc. · 2003 · recalledK042757 · Vanguard SSK Knee System · Biomet, Inc. · 2005 · recalledK093293 · Vanguard 360 Revision Knee System · Biomet, Inc. · 2010 · recalledK122183 · Augment and Screw, Psa Type · United Orthopedic Corp. · 2013K131864 · U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment · United Orthopedic Corporation · 20141985199019952000200520102015
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors3 generations back: 15 other ancestors4 generations back: 10 other ancestors K131864 · U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment · United Orthopedic Corporation · 2014K122183 · Augment and Screw, Psa Type · United Orthopedic Corp. · 2013K093293 · Vanguard 360 Revision Knee System · Biomet, Inc. · 2010 · recalledK042757 · Vanguard SSK Knee System · Biomet, Inc. · 2005 · recalledK023546 · Maxim Accel Knee System · Biomet, Inc. · 2003 · recalledK915132 · MCK Maximum Congruent Knee) Knee System · Biomet, Inc. · 1992 · recalled−50
  1. Root · 6 generations backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
  2. 5 generations backK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
  3. 4 generations backK042757 Vanguard SSK Knee SystemBiomet, Inc. · 2005 · Recalled
  4. 3 generations backK093293 Vanguard 360 Revision Knee SystemBiomet, Inc. · 2010 · Recalled
  5. 2 generations backK122183 Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013
  6. 1 generation backK131864 U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation · 2014
  7. This deviceK152430 All Poly Tibial ComponentUnited Orthopedic Corporation · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K915132MCK Maximum Congruent Knee) Knee SystemBiomet, Inc.19926
−5K023546Maxim Accel Knee SystemBiomet, Inc.200313
−4K042757Vanguard SSK Knee SystemBiomet, Inc.20051
−3K093293Vanguard 360 Revision Knee SystemBiomet, Inc.20105
−2K122183Augment and Screw, Psa TypeUnited Orthopedic Corp.2013—
−1K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation2014—
0 (this device)K152430All Poly Tibial ComponentUnited Orthopedic Corporation2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198710
199110
199310
199410
199550
199630
199710
199810
199910
200030
200130
200210
200310
200410
200530
200610
200720
200810
200910
201110
201410
FIG. 1 — Lineage of K152430, 1992–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K974556Osteonics Scorpio Posterior Cruciate Retaining Total Knee System
Summary page 4
…ics Product Code JWH Predicate Device 1. “OSTEONICS” Osteonics® ScorpioTM Posterior Cruciate Retaining Total Knee System (K974556) 2. “OSTEONICS” Osteonics® ScorpioTM Posteriorly Stabilized Total Knee Syste…
Osteonics Corp.19987
*K962152Osteonics Scorpio Posteriorly Stabilized Total Knee System
Summary page 4
…Retaining Total Knee System (K974556) 2. “OSTEONICS” Osteonics® ScorpioTM Posteriorly Stabilized Total Knee System (K962152) 3. “UNITED” U2 Total Knee System (K051640, K131864) 4. “UNITED” Ultracongruent…
Osteonics Corp.199613
*K051640U2 Total Knee System
Summary page 4
…OSTEONICS” Osteonics® ScorpioTM Posteriorly Stabilized Total Knee System (K962152) 3. “UNITED” U2 Total Knee System (K051640, K131864) 4. “UNITED” Ultracongruent Insert (K132752) Device Description: All Poly Tibial Components…
United Orthopedic Corp.20061
*K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment
Summary page 4
…” Osteonics® ScorpioTM Posteriorly Stabilized Total Knee System (K962152) 3. “UNITED” U2 Total Knee System (K051640, K131864) 4. “UNITED” Ultracongruent Insert (K132752) Device Description: All Poly Tibial Components are made…
United Orthopedic Corporation2014—
*K132752Ultracongruent Insert
Summary page 4
…ized Total Knee System (K962152) 3. “UNITED” U2 Total Knee System (K051640, K131864) 4. “UNITED” Ultracongruent Insert (K132752) Device Description: All Poly Tibial Components are made of Ultra High Molecular Weight Polyethylene UOC-FDA-037…
United Orthopedic Corporation2014—

Also cleared against K974556: 11 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 24 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
  • 30 of the 41 ancestors have a recall of any class.
  • 11 other devices also cite its predicate K974556.

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. 2016, 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 device is indicated for use in total knee arthroplasty in skeletally mature patients with the following conditions: 1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. 2. Collagen disorders, and/or avascular necrosis of the femoral condyle. 3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. 4. Moderate valgus, varus, or flexion deformities. 5.…

Read the full statement (135 words)

The device is indicated for use in total knee arthroplasty in skeletally mature patients with the following conditions:

1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

2. Collagen disorders, and/or avascular necrosis of the femoral condyle.

3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.

4. Moderate valgus, varus, or flexion deformities.

5. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

The device includes Cruciate Retained (CR) type, Posterior Stabilized (PS) type and Ultracongruent (UC) type. CR and UC types are designed to collocate with CR femoral component, while PS type is designed to collocate with PS femoral component.

This device is a single use implant and intended for cemented 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 K974556

11 other devices cite the same predicate.

  • K151266Physica CR Knee SystemLima Corporate S.P.A. · 2015
  • K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon All-Polyethylene Posterior…Howmedica Osteonics Corp. · 2013
  • K113060Unity Toatal Knee SystemCorin USA · 20123 recalls
  • K091280Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc. · 2009
  • K081127Accin Total Knee SystemAccelerated Innovation, LLC · 20081 recall
  • K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc. · 2004

More from United Orthopedic Corporation

41 FDA decisions under this applicant name. See the company

  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K252725Stem Extension Line (U2 Total Knee System—PSA Type)United Orthopedic Corporation · 2025
  • K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation · 2025
  • K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation · 2025
  • K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation · 2025

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/K152430 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152430: All Poly Tibial Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152430

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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