510(k) · Cleared
ClearedMyknee Cutting Blocks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Apr 8, 2010 as substantially equivalent to K082358 (Smith & Nephew, Inc., 2008) and 1 other predicate after a 118-day review. Its family tree reaches back 9 generations to 1994. 16 later devices descend from it.
- Decided
- Apr 8, 2010
- Review
- 118 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K941847 (1994). 86 ancestors in all, the oldest K840643 (1984). 16 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 5 generations between
- 3 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 2 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 1 generation backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- This deviceK093806 Myknee Cutting BlocksMedacta International S.A. · 2010
- Descendant · cites it directly · 12 of its ownK193559 NextAR TKA PlatformMedacta Inernational SA · 2020
- Descendant · 2 generations on · 11 of its ownK202152 NextAR TKA PlatformMedacta International S.A. · 2020
- Descendant · 2 generations on · 5 of its ownK210153 NextAR RSA PlatformMedacta International S.A. · 2021 · Recalled
- Descendant · 2 generations on · 4 of its ownK210859 NextAR™ Spine PlatformMedacta International S.A. · 2021
- Descendant · 3 generations on · 2 of its ownK223769 NextAR™ Spine PlatformMedacta International S.A. · 2023
Show all 9 generations
- Root · 9 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 8 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 7 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 6 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 5 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 4 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 3 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 2 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 1 generation backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- This deviceK093806 Myknee Cutting BlocksMedacta International S.A. · 2010
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K193559NextAR TKA PlatformMedacta Inernational SA · 2020 · cites it directly12descendants
- K202152NextAR TKA PlatformMedacta International S.A. · 2020 · 2 generations on11descendants
- K210153NextAR RSA PlatformMedacta International S.A. · 2021 · 2 generations on5descendants
- K210859NextAR™ Spine PlatformMedacta International S.A. · 2021 · 2 generations on4descendants
- K223769NextAR™ Spine PlatformMedacta International S.A. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −8 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −7 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −6 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −5 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −4 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −3 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −2 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −1 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| 0 (this device) | K093806 | Myknee Cutting Blocks | Medacta International S.A. | 2010 | — |
| +1 | K193559 | NextAR TKA Platform | Medacta Inernational SA | 2020 | — |
| +2 | K202152 | NextAR TKA Platform | Medacta International S.A. | 2020 | — |
| +2 | K210153 | NextAR RSA Platform | Medacta International S.A. | 2021 | 1 |
| +2 | K210859 | NextAR™ Spine Platform | Medacta International S.A. | 2021 | — |
| +3 | K223769 | NextAR™ Spine Platform | Medacta International S.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 8 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K082358 | Smith & Nephew, Inc. Patient Matched TechnologySummary page 1…21 CFR 888.3560 Class 11 Device Product Code: JWH, 000 Predicate Devices: K082358 Smith & Nephew, Inc. Patient Matched Cutting Blocks K090988 GMK Total Kne… | 2008 |
| * | K090988 | GMK Total Knee SystemSummary page 1…e Product Code: JWH, 000 Predicate Devices: K082358 Smith & Nephew, Inc. Patient Matched Cutting Blocks K090988 GMK Total Knee System MyKnee Cutting Blocks 510O(k) Section 5 -Page 2 of 4 Product… | 2009 |
What descends from it? (16)
See all 163 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)
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 16 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 37 of the 85 ancestors have a recall of any class.
- Of its descendants, K193559 (Medacta Inernational SA, 2020) has gone furthest, with 12 descendants of its own.
- 7 other devices also cite its predicate K082358.
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. 2010, 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?
MyKnee Cutting Blocks are intended to be used as anatomical cutting blocks specific for a single patient anatomy to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cuffing.
MyKnee Cutting Blocks are intended for use with GMK Total Knee System and its cleared indications for use.
MyKnee Cutting Blocks are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093806: Myknee Cutting Blocks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093806
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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