510(k) Report

510(k) · Cleared

Cleared

Neo Total Knee System

K142388510(k) TraditionalCleared Dec 5, 2014100-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

New Era Orthopedics, LLC · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Dec 5, 2014 as substantially equivalent to K120313 (Pipeline Orthopedics, 2012) and 2 other predicates after a 100-day review. Its family tree reaches back 7 generations to 1995.

Decided
Dec 5, 2014
Review
100 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
3

Its longest line of descent runs back 7 generations to K933785 (1995). 28 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2013: 1 other ancestor2007: 3 other ancestors2004: 3 other ancestors2003: 4 other ancestors1999: 1 other ancestor2005: 3 other ancestors2002: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestorK933785 · Next Generation Knee System · Zimmer, Inc. · 1995 · recalledK023211 · Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components · Zimmer, Inc. · 2002 · recalledK060370 · Nexgen Knee Gender Solutions Female (GSF) Femoral Components · Zimmer, Inc. · 2006 · recalledK070214 · Gender Solutions Natural-Knee Flex System · Zimmer, Inc. · 2007 · recalledK073286 · Gender Solutions Natural-Knee Flex System · Zimmer, Inc. · 2008 · recalledK120313 · Neo CR Knee System · Pipeline Orthopedics · 2012K122500 · Neo PS Knee System · Pipeline Orthopedics · 201319952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 6 other ancestors3 generations back: 9 other ancestors4 generations back: 5 other ancestors K122500 · Neo PS Knee System · Pipeline Orthopedics · 2013K120313 · Neo CR Knee System · Pipeline Orthopedics · 2012K073286 · Gender Solutions Natural-Knee Flex System · Zimmer, Inc. · 2008 · recalledK070214 · Gender Solutions Natural-Knee Flex System · Zimmer, Inc. · 2007 · recalledK060370 · Nexgen Knee Gender Solutions Female (GSF) Femoral Components · Zimmer, Inc. · 2006 · recalledK023211 · Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components · Zimmer, Inc. · 2002 · recalledK933785 · Next Generation Knee System · Zimmer, Inc. · 1995 · recalled−50
  1. Root · 7 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
  2. 6 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
  3. 5 generations backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
  4. 4 generations backK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
  5. 3 generations backK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
  6. 2 generations backK120313 Neo CR Knee SystemPipeline Orthopedics · 2012
  7. 1 generation backK122500 Neo PS Knee SystemPipeline Orthopedics · 2013
  8. This deviceK142388 Neo Total Knee SystemNew Era Orthopedics, LLC · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K933785Next Generation Knee SystemZimmer, Inc.199583
−6K023211Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral ComponentsZimmer, Inc.20026
−5K060370Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc.200617
−4K070214Gender Solutions Natural-Knee Flex SystemZimmer, Inc.200763
−3K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc.20085
−2K120313Neo CR Knee SystemPipeline Orthopedics2012—
−1K122500Neo PS Knee SystemPipeline Orthopedics2013—
0 (this device)K142388Neo Total Knee SystemNew Era Orthopedics, LLC2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199910
200010
200120
200210
200340
200430
200530
200730
201310
FIG. 1 — Lineage of K142388, 1995–2014Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K120313Neo CR Knee System
Summary page 4
…on To obtain 510(k)s under the name of the New Era Orthopedics, LLC for the same NEO Total Knee System, with minor dimensional changes, as previously cleared in 510(k)s #K120313, K122500, and K131368. Device Description: The NEO Total Knee System includes: • Cruciate retaining (CR) Femoral Components and…
Pipeline Orthopedics2012—
*K122500Neo PS Knee System
Summary page 4
…ain 510(k)s under the name of the New Era Orthopedics, LLC for the same NEO Total Knee System, with minor dimensional changes, as previously cleared in 510(k)s #K120313, K122500, and K131368. Device Description: The NEO Total Knee System includes: • Cruciate retaining (CR) Femoral Components and Posterior…
Pipeline Orthopedics2013—
*K131368Neo Knee System
Summary page 4
…nder the name of the New Era Orthopedics, LLC for the same NEO Total Knee System, with minor dimensional changes, as previously cleared in 510(k)s #K120313, K122500, and K131368. Device Description: The NEO Total Knee System includes: • Cruciate retaining (CR) Femoral Components and Posteriorly stabilized…
Pipeline Orthopedics2013—

Also cleared against K120313: 2 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 19 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • 17 of the 28 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K120313.

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. 2014, 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 NEO Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, undergoing surgery for total knee replacement due to: x Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis. x Failed osteotomies, failed partial knee replacement, or failed total knee replacement whose age, weight and activity level are compatible with an…

Read the full statement (158 words)

The NEO Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, undergoing surgery for total knee replacement due to:

x Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate

deformities and femoral condyle osteonecrosis.

x Failed osteotomies, failed partial knee replacement, or failed total knee

replacement whose age, weight and activity level are compatible with an

adequate long-term result.

x Post-traumatic loss of joint configuration, particularly when there is

patellofemoral erosion, dysfunction or prior patellectomy.

x Moderate valgus, varus, or flexion deformities.

The cruciate retaining (CR) femur with CR tibial insert is for use when the posterior

cruciate ligament (PCL) is intact. The CR femur with UC tibial inserts is for use when the

PCL is sacrificed. The posteriorly stabilized (PS) femur with PS tibial insert is for use

when the PCL is sacrificed.

The NEO Total Knee System components are indicated for use only with cement and are

single use devices.

Indications for use as stated in the FDA summary.

Also cleared against K120313

2 other devices cite the same predicate.

  • K131368Neo Knee SystemPipeline Orthopedics · 2013
  • K122500Neo PS Knee SystemPipeline Orthopedics · 2013

More from New Era Orthopedics, LLC

2 FDA decisions under this applicant name. See the company

  • K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC · 20151 recall

Recent decisions in JWH

The JWH category page

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  • 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/K142388 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142388: Neo 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/K142388

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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