510(k) · Cleared
ClearedPipeline 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 May 24, 2013 as substantially equivalent to K113122 (Pipeline Orthopedics, 2012) and 8 other predicates after a 172-day review. Its family tree reaches back 12 generations to 1981.
- Decided
- May 24, 2013
- Review
- 172 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 12 generations to K810258 (1981). 193 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations between
- 3 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 2 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 1 generation backK111481 Corin Trinity Acetabular System Ecima LinersCorin USA · 2012 · Recalled
- This deviceK123692 Pipeline Knee SystemPipeline Orthopedics · 2013
Show all 12 generations
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 11 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 10 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 9 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 8 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 7 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 6 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 5 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 4 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 3 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 2 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 1 generation backK111481 Corin Trinity Acetabular System Ecima LinersCorin USA · 2012 · Recalled
- This deviceK123692 Pipeline Knee SystemPipeline Orthopedics · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −11 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −10 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −9 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −8 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −7 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −6 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −5 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −4 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −3 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −2 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −1 | K111481 | Corin Trinity Acetabular System Ecima Liners | Corin USA | 2012 | 1 |
| 0 (this device) | K123692 | Pipeline Knee System | Pipeline Orthopedics | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 4 | 0 |
| 1993 | 6 | 0 |
| 1994 | 19 | 0 |
| 1995 | 13 | 0 |
| 1996 | 12 | 0 |
| 1997 | 9 | 0 |
| 1998 | 5 | 0 |
| 1999 | 6 | 0 |
| 2000 | 14 | 0 |
| 2001 | 10 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 11 | 0 |
| 2005 | 8 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 7 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 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? (12)
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 |
|---|---|---|---|
| * | K113122 | Pipeline CR Primary Knee SystemSummary page 1…f this 510(k) represents an evolution of the component designs and a line extension to the original Pipeline Knee System cleared by the FDA on March 20, 2012 via 510(k) #K113122. Intended Use: The Pipeline Knee System is indicated for skeletally mature patients with severe knee pain and disability due to:… | 2012 |
| * | K040267 | Triathlon Cruciate Retaining (CR) Total KneeSummary page 2…51.0(K) # Pipeline CR Total Knee System Pipeline K113122 Triathlon Knee Systems Stryker K040267 Evolution MP (medial pivot) Total Wright Medical K093552 Knee Systems Tech… | 2004 |
| * | K093552 | Evolution MP Total Knee SystemSummary page 2…K113122 Triathlon Knee Systems Stryker K040267 Evolution MP (medial pivot) Total Wright Medical K093552 Knee Systems Technology Journey 11Knee System: K… | 2010 |
| * | K121443 | Journey II CR Knee SystemSummary page 2…Wright Medical K093552 Knee Systems Technology Journey 11Knee System: K121443 CR Knee System, Sih&Npe 138 Deep Dished Articular Insert, Smt ehwK… | 2012 |
| * | K111711 | Journey II BCS Knee SystemSummary page 2…K121443 CR Knee System, Sih&Npe 138 Deep Dished Articular Insert, Smt ehwK111711 BCS Knee SystemK171 Persona Personalized Knee (CR, UC, Zimmer K113369 PS Inserts) Corin Trinity… | 2011 |
| * | K113369 | Zimmer Persona Knee SystemSummary page 2…138 Deep Dished Articular Insert, Smt ehwK111711 BCS Knee SystemK171 Persona Personalized Knee (CR, UC, Zimmer K113369 PS Inserts) Corin Trinity Acetabular System Corin USA K111481 ECIMA Liners Vanguard Patellar Compon… | 2012 |
| * | K111481 | Corin Trinity Acetabular System Ecima LinersSummary page 2…mK171 Persona Personalized Knee (CR, UC, Zimmer K113369 PS Inserts) Corin Trinity Acetabular System Corin USA K111481 ECIMA Liners Vanguard Patellar Components Biomet K040770 Total Cruciate Retaining Knee… | 2012 |
| * | K040770 | Vanguard Patella ComponentsSummary page 2…rts) Corin Trinity Acetabular System Corin USA K111481 ECIMA Liners Vanguard Patellar Components Biomet K040770 Total Cruciate Retaining Knee ConforMIS Inc. K122870 Replacement System with iPoly XE Tibial Inserts a… | 2004 |
| * | K122870 | Itotal Cruciate Retaining (CR) Knee Replacement System Cleared while this submission was under review Summary page 2…1481 ECIMA Liners Vanguard Patellar Components Biomet K040770 Total Cruciate Retaining Knee ConforMIS Inc. K122870 Replacement System with iPoly XE Tibial Inserts and Patellae Natural Knee 11Durasul Tibial Insert Sulzer Orthopedics… | 2013 |
| Kept off the family tree | K000235 | FDA’s K000235 is Insyte Catheter, Insyte Autoguard Catheter Our reading of the summary gave K000235, FDA’s number for Insyte Catheter, Insyte Autoguard Catheter (Becton Dickinson Infusion Therapy Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Natural Knee II Durasul Tibial Insert and Patella”. Kept off the family tree. | 2000 |
| * | — | CR Knee System Named without a submission number | |
| * | — | BCS Knee System Named without a submission number |
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 32 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 77 of the 192 ancestors have a recall of any class.
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 Pipeline Knee System is indicated for skeletally mature patients with severe knee pain and disability due to: * Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, * Collagen disorders, and/or avascular necrosis of the femoral condyle, * Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, * Moderate valgus, varus, or flexion deformities, * The salvage…
Read the full statement (101 words)
The Pipeline Knee System is indicated for skeletally mature patients with severe knee pain and disability due to:
* Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis,
* Collagen disorders, and/or avascular necrosis of the femoral condyle,
* Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy,
* Moderate valgus, varus, or flexion deformities,
* The salvage of previously tailed surgical attempts or for a knee in which satisfactory stability in flexion cannot otherwise be obtained at the time of surgery..
Pipeline 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/K123692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123692: Pipeline 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/K123692
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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