510(k) · Cleared
ClearedCOPAL knee moulds
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Medical GmbH · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Feb 4, 2023 as substantially equivalent to K032522 (Exactech, Inc., 2004) after a 165-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Feb 4, 2023
- Review
- 165 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K936159 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK936159 Natural-Knee II SystemIntermedics Orthopedics · 1995 · Recalled
- 1 generation backK032522 Tecres Spacer-K Temporary Knee ProsthesisExactech, Inc. · 2004
- This deviceK222570 COPAL knee mouldsHeraeus Medical GmbH · 2023
- Descendant · cites it directly · 0 of its ownK243024 Cellbrick Knee SpacerUnited Orthopedic Corporation · 2024
Most influential descendants
Showing 1 of 1 · See all- K243024Cellbrick Knee SpacerUnited Orthopedic Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K936159 | Natural-Knee II System | Intermedics Orthopedics | 1995 | 6 |
| −1 | K032522 | Tecres Spacer-K Temporary Knee Prosthesis | Exactech, Inc. | 2004 | — |
| 0 (this device) | K222570 | COPAL knee moulds | Heraeus Medical GmbH | 2023 | — |
| +1 | K243024 | Cellbrick Knee Spacer | United Orthopedic Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K032522 | Tecres Spacer-K Temporary Knee ProsthesisSummary page 4…3560) Regulatory Class: Class II Product Code: JWH Subsequent Product Code(s): Not applicable III. PREDICATE DEVICES Tecres Spacer-K (K032522) Page 1 of 4… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243024 | Cellbrick Knee Spacer | 2024 | 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 28 years and passes through 3 companies; a new generation was cleared every 18.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K243024 (United Orthopedic Corporation, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K032522.
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. 2023, 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?
COPAL® knee moulds are designed to prepare spacers by filling the moulds with bone cement. COPAL® knee moulds are disposable cement spacer molds indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee spacer is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (PALACOS® R+G bone cement), the molded temporary spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222570: COPAL knee moulds.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222570
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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