510(k) · Cleared
ClearedMectaplug PE II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · JDK Prosthesis, Hip, Cement Restrictor
Cleared on Apr 8, 2021 as substantially equivalent to K021765 (Exactech, Inc., 2002) and 4 other predicates after an 87-day review. Its family tree reaches back 14 generations to 1994.
- Decided
- Apr 8, 2021
- Review
- 87 days
- Class
- Class II
- Product code
- JDK
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 14 generations to K941847 (1994). 170 ancestors in all, the oldest K791125 (1979). No later device cites it as a predicate yet.
- Root · 14 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 10 generations between
- 3 generations backK120790 GMK - Line ExtensionMedacta International · 2012
- 2 generations backK122232 GMK NarrowMedacta International · 2012
- 1 generation backK131310 GMK Full PE Tibial ComponentsMedacta International · 2013
- This deviceK210062 Mectaplug PE IIMedacta International S.A. · 2021
Show all 14 generations
- Root · 14 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 13 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 12 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 11 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 10 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 9 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 8 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 7 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 6 generations backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- 5 generations backK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- 4 generations backK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
- 3 generations backK120790 GMK - Line ExtensionMedacta International · 2012
- 2 generations backK122232 GMK NarrowMedacta International · 2012
- 1 generation backK131310 GMK Full PE Tibial ComponentsMedacta International · 2013
- This deviceK210062 Mectaplug PE IIMedacta International S.A. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −13 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −12 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −11 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −10 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −9 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −8 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −7 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −6 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| −5 | K102437 | GMK Revision Knee System | Medacta International S.A. | 2010 | — |
| −4 | K103170 | GMK Revision Knee SC Liners | Medacta International S.A. | 2011 | — |
| −3 | K120790 | GMK - Line Extension | Medacta International | 2012 | — |
| −2 | K122232 | GMK Narrow | Medacta International | 2012 | — |
| −1 | K131310 | GMK Full PE Tibial Components | Medacta International | 2013 | — |
| 0 (this device) | K210062 | Mectaplug PE II | Medacta International S.A. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 11 | 0 |
| 1995 | 8 | 0 |
| 1996 | 19 | 0 |
| 1997 | 6 | 0 |
| 1998 | 8 | 0 |
| 1999 | 7 | 0 |
| 2000 | 16 | 0 |
| 2001 | 9 | 0 |
| 2002 | 13 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 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 JDK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K021765 | Cement Restrictor, Small and LargeSummary page 4…JDK Regulation Number: 21 CFR 878.3300 Device Classification II III. Predicate Device Primary predicate device: * Tecres Cement Restrictors, K021765, Tecres S.p.A. Reference predicate: * Femoral Cement Restrictors, K800144, Biomet Inc. * BUCK cement restrictors, K791125,… | 2002 |
| * | K800144 | Femoral Cement RestrictorSummary page 4…II III. Predicate Device Primary predicate device: * Tecres Cement Restrictors, K021765, Tecres S.p.A. Reference predicate: * Femoral Cement Restrictors, K800144, Biomet Inc. * BUCK cement restrictors, K791125, Smith & Nephew * Quadra P, K192827, Medacta Intemational * GMK Full PE… | 1980 |
| * | K791125 | Plug-Lok Cement RestirctorSummary page 4…device: * Tecres Cement Restrictors, K021765, Tecres S.p.A. Reference predicate: * Femoral Cement Restrictors, K800144, Biomet Inc. * BUCK cement restrictors, K791125, Smith & Nephew * Quadra P, K192827, Medacta Intemational * GMK Full PE Tibial components, KI31310, Medacta International S… | 1979 |
| * | K192827 | Quadra-PSummary page 4…, K021765, Tecres S.p.A. Reference predicate: * Femoral Cement Restrictors, K800144, Biomet Inc. * BUCK cement restrictors, K791125, Smith & Nephew * Quadra P, K192827, Medacta Intemational * GMK Full PE Tibial components, KI31310, Medacta International SA IV. Device Description MectaPlug… | 2020 |
| * | K131310 | GMK Full PE Tibial Components | 2013 |
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 27 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 57 of the 169 ancestors have a recall of any class.
How does its category compare?
All JDK devicesJDK Prosthesis, Hip, Cement Restrictor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · JDK
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JDK
Too few JDK 510(k)s in any year since 2007 to give a median.
Recalls per year · JDK
5in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDK
6in 2025
MAUDE reports naming product code JDK, 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 | 0 | — | 6 | 3 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 5 | 3 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
MectaPlug PE II is an intramedullary cement restrictor, designed to seal the intramedullary canal prior to cementation in total or partial hip arthroplasty, for primary or revision surgery. Total hip arthroplasty is indicated in the following cases: * Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia * Avascular necrosis of the femoral head * Acute traumatic fracture…
Read the full statement (138 words)
MectaPlug PE II is an intramedullary cement restrictor, designed to seal the intramedullary canal prior to cementation in total or partial hip arthroplasty, for primary or revision surgery.
Total hip arthroplasty is indicated in the following cases:
* Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia
* Avascular necrosis of the femoral head
* Acute traumatic fracture of the femoral head or neck
* Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty
Partial hip arthroplasty is indicated in the following cases:
* Acute traumatic fracture of the femoral head or neck
* Non-union of femoral neck fracture
* Avascular necrosis of the femoral head
* Primary pathology involving the femoral head, but with a non-defonned acetabulum
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210062: Mectaplug PE II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210062
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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