510(k) · Cleared
ClearedNeo Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pipeline Orthopedics · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Oct 3, 2013 as substantially equivalent to K120313 (Pipeline Orthopedics, 2012) and 1 other predicate after a 143-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.
- Decided
- Oct 3, 2013
- Review
- 143 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K933785 (1995). 22 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 5 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 4 generations backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
- 3 generations backK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- 2 generations backK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- 1 generation backK120313 Neo CR Knee SystemPipeline Orthopedics · 2012
- This deviceK131368 Neo Knee SystemPipeline Orthopedics · 2013
- Descendant · cites it directly · 0 of its ownK142388 Neo Total Knee SystemNew Era Orthopedics, LLC · 2014
Most influential descendants
Showing 1 of 1 · See all- K142388Neo Total Knee SystemNew Era Orthopedics, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −5 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −4 | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral Components | Zimmer, Inc. | 2006 | 17 |
| −3 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| −2 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| −1 | K120313 | Neo CR Knee System | Pipeline Orthopedics | 2012 | — |
| 0 (this device) | K131368 | Neo Knee System | Pipeline Orthopedics | 2013 | — |
| +1 | K142388 | Neo Total Knee System | New Era Orthopedics, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
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
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K120313 | Neo CR Knee SystemSummary page 1…(973) 267-8810 Date Summary Prepared: May 10, 2013 Device Description: The NEO Total Knee System was cleared for marketing in April 2012, under 510(k) #K120313. The predicate knee system includes a cruciate retaining (CR) femoral component design, tibial trays, CR tibial inserts for use w… | 2012 |
| * | K063423 | Triathlon CS (Condylar Stabilizing) Lipped InsertSummary page 2…Stry'ker Orthopaedlics stailiing tiialinsrts(Stryker Howmedica K063423 01/22/2007 stabilizig) tibia insertsOsteonics)… | 2007 |
| Kept off the family tree | K114821 | Journey II Deep Dished Articular Inserts Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…Smith & Nephew K142 0/721 Inserts I Orthopaedlics K114821 0/27201 I____ Purpose of… |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142388 | Neo Total Knee System | 2014 | 0 |
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 18 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 13 of the 22 ancestors have a recall of any class.
- Of its descendants, K142388 (New Era Orthopedics, LLC, 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K120313.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 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 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: * Osteoarthritis, rheumatoid arthritis, past-traumatic arthritis, moderate deformities and femnoral condyle osteonecrosis. * 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 (106 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:
* Osteoarthritis, rheumatoid arthritis, past-traumatic arthritis, moderate deformities and femnoral condyle osteonecrosis.
* 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.
* Post-traumatic loss of joint configuration, particularly when there Is patellofemoral erosion, dysfunction or prior patellectomy.
* Moderate valgus, varus, or flexion deformities.
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.
https://510kreport.com/device/K131368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131368: Neo 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/K131368
Report an extraction error
Are you the manufacturer?
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