510(k) · Cleared
ClearedMyKnee R Pin Positioners
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 May 4, 2022 as substantially equivalent to K170106 (Medacta International S.A., 2017) after a 55-day review. Its family tree reaches back 11 generations to 1994.
- Decided
- May 4, 2022
- Review
- 55 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K941847 (1994). 88 ancestors in all, the oldest K840643 (1984). No later device cites it as a predicate yet.
- Root · 11 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 7 generations between
- 3 generations backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- 2 generations backK093806 Myknee Cutting BlocksMedacta International S.A. · 2010
- 1 generation backK170106 MyKnee PPS-Pin PositionersMedacta International S.A. · 2017
- This deviceK220705 MyKnee R Pin PositionersMedacta International S.A. · 2022
Show all 11 generations
- Root · 11 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 10 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 9 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 8 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 7 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 6 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 5 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 4 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 3 generations backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- 2 generations backK093806 Myknee Cutting BlocksMedacta International S.A. · 2010
- 1 generation backK170106 MyKnee PPS-Pin PositionersMedacta International S.A. · 2017
- This deviceK220705 MyKnee R Pin PositionersMedacta International S.A. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −10 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −9 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −8 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −7 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −6 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −5 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −4 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −3 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| −2 | K093806 | Myknee Cutting Blocks | Medacta International S.A. | 2010 | — |
| −1 | K170106 | MyKnee PPS-Pin Positioners | Medacta International S.A. | 2017 | — |
| 0 (this device) | K220705 | MyKnee R Pin Positioners | Medacta International S.A. | 2022 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K170106 | MyKnee PPS-Pin PositionersSummary page 4…assification II III. Predicate Device Substantial equivalence is claimed to the following primary predicate device: MyKnee PPS-Pin Positioners, K170106, Medacta Interational SA In addition, the following reference device is cited within the submission: My Knee Cutting B… | 2017 |
| † | K093806 | Myknee Cutting Blocks | 2010 |
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 28 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 37 of the 87 ancestors have a recall of any class.
- 1 other device also cites its predicate K170106.
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. 2022, 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® R Pin Positioners are intended for use as anatomical pin positioners specific for a single patient anatomy in case of revision total knee replacement. They are designed based on CT images of a patient’s knee and the primary TKA implant in situ to assist in positioning the total knee replacement components intraoperatively and in guiding the marking of bone prior to cutting. MyKnee® R Pin Positioners are intended for single use only. Resections…
Read the full statement (142 words)
MyKnee® R Pin Positioners are intended for use as anatomical pin positioners specific for a single patient anatomy in case of revision total knee replacement. They are designed based on CT images of a patient’s knee and the primary TKA implant in situ to assist in positioning the total knee replacement components intraoperatively and in guiding the marking of bone prior to cutting. MyKnee® R Pin Positioners are intended for single use only. Resections are performed through the standard or revision cutting guides. These are positioned on the pins placed in the holes drilled through the MyKnee® R Pin Positioner blocks after removal of the primary total knee implant components and according to the surgeon’s preoperative planning. MyKnee® R Pin Positioners are intended for use with GMK® Primary, GMK® Sphere, GMK® SpheriKA, GMK® Revision, GMK® Hinge and their cleared indications for use.
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/K220705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220705: MyKnee R Pin Positioners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220705
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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