510(k) · Cleared
ClearedPipeline CR Primary 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 Mar 20, 2012 as substantially equivalent to K023211 (Zimmer, Inc., 2002) and 1 other predicate after a 151-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Mar 20, 2012
- Review
- 151 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K933785 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 1 generation backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- This deviceK113122 Pipeline CR Primary Knee SystemPipeline Orthopedics · 2012
- Descendant · cites it directly · 0 of its ownK123692 Pipeline Knee SystemPipeline Orthopedics · 2013
Most influential descendants
Showing 1 of 1 · See all- K123692Pipeline Knee SystemPipeline Orthopedics · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −1 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| 0 (this device) | K113122 | Pipeline CR Primary Knee System | Pipeline Orthopedics | 2012 | — |
| +1 | K123692 | Pipeline Knee System | Pipeline Orthopedics | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral ComponentsSummary page 2…Date NexGen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Zimmer K023211 10/17/2002 Components Gender Solutions Natural-Knee FlexZimrK726 0//08 SystemZimr… | 2002 |
| Kept off the family tree | K072726 | Gender Solutions Natural-Knee Flex System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K040267 | Triathlon Cruciate Retaining (CR) Total KneeSummary page 2…0//08 SystemZimr K726 0/708 Triathlon Cruciate Retaining (Cr) Total Stryker K040267 5/5/2004 Knee System _______ ______ _____ Technological* Characteristic… | 2004 |
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 |
|---|---|---|---|
| K123692 | Pipeline Knee System | 2013 | 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 17 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K123692 (Pipeline Orthopedics, 2013) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K023211.
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. 2012, 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 Pipeline CR Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing total knee replacement due to: * Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis. * Failed osteotomies, failed partial knee replacement, or failed prior total knee replacement whose age, weight…
Read the full statement (112 words)
The Pipeline CR Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing total knee replacement due to:
* Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
* Failed osteotomies, failed partial knee replacement, or failed prior 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.
Pipeline CR 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/K113122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113122: Pipeline CR Primary 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/K113122
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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