510(k) · Cleared
ClearedItotal Cruciate Retaining (CR) Knee Replacement System
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 Jan 14, 2013 as substantially equivalent to K120316 (Conformis, Inc., 2012) and 9 other predicates after a 117-day review. Its family tree reaches back 8 generations to 1981. 33 later devices descend from it.
- Decided
- Jan 14, 2013
- Review
- 117 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 8 generations to K810258 (1981). 74 ancestors in all. 33 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 6 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 5 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 4 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 3 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 2 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- 1 generation backK103223 Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P. · 2010
- This deviceK122870 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
- Descendant · cites it directly · 30 of its ownK131467 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
- Descendant · cites it directly · 30 of its ownK131019 Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013
- Descendant · 2 generations on · 26 of its ownK140833 Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014
- Descendant · 2 generations on · 25 of its ownK140423 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 24 of its ownK142404 iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · Recalled
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013 · cites it directly30descendants
- K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013 · cites it directly30descendants
- K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · 2 generations on26descendants
- K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2014 · 2 generations on25descendants
- K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · 3 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −7 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −6 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −5 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −4 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −3 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −2 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| −1 | K103223 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts | Encore Medical L.P. | 2010 | — |
| 0 (this device) | K122870 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2013 | — |
| +1 | K131467 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2013 | — |
| +1 | K131019 | Itotal Cruciate Retaining (C) Knee Replacement System | Conformis, Inc. | 2013 | — |
| +2 | K140833 | Itotal Posterior Stabilized (PS) Knee Replacement System | Conformis, Inc. | 2014 | — |
| +2 | K140423 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2014 | 1 |
| +3 | K142404 | iTotal Posterior Stabilized (PS) Knee Replacement System | Conformis, Inc. | 2014 | 2 |
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 | 4 | 0 |
| 1993 | 4 | 0 |
| 1994 | 8 | 0 |
| 1995 | 8 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2018 | 1 | 0 |
| 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? (10)
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 |
|---|---|---|---|
| * | K120316 | Itotal Cruciate Retaining (CR) Knee Replacement SystemSummary page 2…Devices Product Code: JWH, COG (Predicate Devices) Regulation Number: 21 CFR 888.3560 510(k) number: K120316, K120068, K113378, K112780, K103117, K094050 Biome… | 2012 |
| * | K120068 | Conformis Itotal CR Knee Replacement System (KRS)Summary page 2…Product Code: JWH, COG (Predicate Devices) Regulation Number: 21 CFR 888.3560 510(k) number: K120316, K120068, K113378, K112780, K103117, K094050 Biomet E-PolyT… | 2012 |
| * | K113378 | Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemSummary page 2…Product Code: JWH, COG (Predicate Devices) Regulation Number: 21 CFR 888.3560 510(k) number: K120316, K120068, K113378, K112780, K103117, K094050 Biomet E-PolyTM Tibial… | 2012 |
| * | K112780 | Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemSummary page 2…Product Code: JWH, COG (Predicate Devices) Regulation Number: 21 CFR 888.3560 510(k) number: K120316, K120068, K113378, K112780, K103117, K094050 Biomet E-PolyTM Tibial Bearings… | 2011 |
| * | K103117 | Itotal Cruciate Retaining (CR) Knee Replacement SystemSummary page 2…Code: JWH, COG (Predicate Devices) Regulation Number: 21 CFR 888.3560 510(k) number: K120316, K120068, K113378, K112780, K103117, K094050 Biomet E-PolyTM Tibial Bearings… | 2011 |
| * | K094050 | Itotal CR Knee Replacement SystemSummary page 2…ion Number: 21 CFR 888.3560 510(k) number: K120316, K120068, K113378, K112780, K103117, K094050 Biomet E-PolyTM Tibial Bearings Device Class: 11… | 2010 |
| * | K080528 | E-Poly Tibial BearingsSummary page 2…Product Code: JWH, MBH, MBV, OlY Regulation Number: 21 CFR 888.3560 510(k) number: K080528 OJO Surgical Highly Cross-Li nked Vitamin E UHMWPE Tibial Insert and P… | 2008 |
| * | K113756 | Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Summary page 3…fZ- Regulation Number: 21 CFR 888.3560 510(k) number: K113756, K103223, K091956 510(k) Sumnmary continued Device Description, The iTotal Cruciate Retaining Knee Replacement System (… | 2012 |
| * | K103223 | Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsSummary page 3…fZ- Regulation Number: 21 CFR 888.3560 510(k) number: K113756, K103223, K091956 510(k) Sumnmary continued Device Description, The iTotal Cruciate Retaining Knee Replacement System (hereafter… | 2010 |
| * | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Summary page 3…fZ- Regulation Number: 21 CFR 888.3560 510(k) number: K113756, K103223, K091956 510(k) Sumnmary continued Device Description, The iTotal Cruciate Retaining Knee Replacement System (hereafter… | 2010 |
What descends from it? (33)
See all 335 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131467 | Itotal Cruciate Retaining (CR) Knee Replacement System | 2013 | 30 |
| K131019 | Itotal Cruciate Retaining (C) Knee Replacement System | 2013 | 30 |
| K161366 | ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) | 2016 | 18 |
| K133560 | Itotal Cruciate Retaining Knee Replacment System | 2014 | 0 |
| 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 32 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 32 of the 74 ancestors have a recall of any class.
- Of its descendants, K131467 (Conformis, Inc., 2013) has gone furthest, with 30 descendants of its own.
- 3 other devices also cite its predicate K120316.
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 iTotal® CR 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 (142 words)
The iTotal® CR 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 or osteonecrosis of the knee.
* Post traumatic loss of joint function.
* Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
* 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.
The implant is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122870 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122870: Itotal Cruciate Retaining (CR) Knee Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122870
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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