510(k) · Cleared
Recalled · Class II · 2020ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conformis, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jul 15, 2016 as substantially equivalent to K160025 (Conformis, Inc., 2016) and 1 other predicate after a 29-day review. Its family tree reaches back 14 generations to 1981. 17 later devices descend from it. It has been recalled 4 times.
- Decided
- Jul 15, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 14 generations to K810258 (1981). 112 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations between
- 3 generations backK142161 Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal…Conformis, Inc. · 2014 · Recalled
- 2 generations backK152704 iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate…Conformis, Inc. · 2015
- 1 generation backK153217 ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2016
- This deviceK161668 ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement…Conformis, Inc. · 2016
- Descendant · cites it directly · 15 of its ownK193105 iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee…Conformis, Inc. · 2020
- Descendant · cites it directly · 15 of its ownK190562 iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019
- Descendant · cites it directly · 14 of its ownK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020
- Descendant · 2 generations on · 12 of its ownK203447 iTotal Identity Cruciate Retaining (CR) Total Knee Replacement…Conformis, Inc. · 2020
- Descendant · 2 generations on · 10 of its ownK210191 Identity Imprint Knee Replacement SystemConformis, Inc. · 2021 · Recalled
Show all 14 generations
- Root · 14 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 13 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 12 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 11 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 10 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 9 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 8 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- 7 generations backK103223 Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P. · 2010
- 6 generations backK122870 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
- 5 generations backK131019 Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013
- 4 generations backK140423 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2014 · Recalled
- 3 generations backK142161 Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal…Conformis, Inc. · 2014 · Recalled
- 2 generations backK152704 iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate…Conformis, Inc. · 2015
- 1 generation backK153217 ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2016
- This deviceK161668 ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement…Conformis, Inc. · 2016
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc. · 2020 · cites it directly15descendants
- K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019 · cites it directly15descendants
- K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020 · cites it directly14descendants
- K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc. · 2020 · 2 generations on12descendants
- K210191Identity Imprint Knee Replacement SystemConformis, Inc. · 2021 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −13 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −12 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −11 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −10 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −9 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −8 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| −7 | K103223 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts | Encore Medical L.P. | 2010 | — |
| −6 | K122870 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2013 | — |
| −5 | K131019 | Itotal Cruciate Retaining (C) Knee Replacement System | Conformis, Inc. | 2013 | — |
| −4 | K140423 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2014 | 1 |
| −3 | K142161 | Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior… | Conformis, Inc. | 2014 | 6 |
| −2 | K152704 | iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining… | Conformis, Inc. | 2015 | — |
| −1 | K153217 | ConforMIS iTotal Posterior Stabilized Knee Replacement System | Conformis, Inc. | 2016 | — |
| 0 (this device) | K161668 | ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal… | Conformis, Inc. | 2016 | — |
| +1 | K193105 | iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair… | Conformis, Inc. | 2020 | — |
| +1 | K190562 | iTotal Identity Cruciate Retaining Knee Replacement System | Conformis, Inc. | 2019 | — |
| +1 | K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | Conformis, Inc. | 2020 | — |
| +2 | K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal… | Conformis, Inc. | 2020 | — |
| +2 | K210191 | Identity Imprint Knee Replacement System | Conformis, Inc. | 2021 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 9 | 0 |
| 1995 | 11 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2025 | 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? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160025 | iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Summary page 5…Product Code: JWH, OOG, OIY Regulation Number: 21 CFR 888.3560 510(k) Number: K160025 & K153217 Special 510(k) – iTotal PS® KRS – iJig Software Modifications… | 2016 |
| * | K153217 | ConforMIS iTotal Posterior Stabilized Knee Replacement SystemSummary page 5…ode: JWH, OOG, OIY Regulation Number: 21 CFR 888.3560 510(k) Number: K160025 & K153217 Special 510(k) – iTotal PS® KRS – iJig Software Modifications… | 2016 |
What descends from it? (17)
See all 173 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 3, 2020 | Class II | Z-1628-2020 | Mixed-up of materials/components | A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts. |
| Jan 4, 2019 | Class II | Z-1079-2019 | Employee error | The labeling of the boxes and sterile pouches did not match the contents. |
| Jul 24, 2017 | Class II | Z-0600-2018 | Employee error | Implant kit mislabeled |
| Oct 31, 2016 | Class II | Z-0991-2017 | Software Design Change | iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 53 of the 112 ancestors have a recall of any class.
- Of its descendants, K193105 (Conformis, Inc., 2020) has gone furthest, with 15 descendants of its own.
- 1 other device also cites its predicate K160025.
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. 2016, 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 iTotal® PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: - Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid…
Read the full statement (130 words)
The iTotal® PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
- Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, polyarthritis or osteonecrosis of the knee.
- Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity.
- Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
- Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans
This implant is 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.
https://510kreport.com/device/K161668 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161668: ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161668
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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