510(k) · Cleared
ClearedCOPAL exchange G Hip and Knee Spacers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Medical GmbH · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Nov 1, 2019 as substantially equivalent to K101356 (Tecres S.P.A., 2011) after a 198-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Nov 1, 2019
- Review
- 198 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K936159 (1995). 13 ancestors in all, the oldest P810020 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK936159 Natural-Knee II SystemIntermedics Orthopedics · 1995 · Recalled
- 4 generations backK032522 Tecres Spacer-K Temporary Knee ProsthesisExactech, Inc. · 2004
- 3 generations backK050210 Disposable Cement Spacer Molds for Temporary Knee ProsthesesBiomet, Inc. · 2005 · Recalled
- 2 generations backK062274 Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021…Tecres S.P.A. · 2008
- 1 generation backK101356 Spacer-G and Spacer-KTecres S.P.A. · 2011
- This deviceK191016 COPAL exchange G Hip and Knee SpacersHeraeus Medical GmbH · 2019
- Descendant · cites it directly · 0 of its ownK220492 COPAL exchange G hip spacerHeraeus Medical GmbH · 2022
Most influential descendants
Showing 1 of 1 · See all- K220492COPAL exchange G hip spacerHeraeus Medical GmbH · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K936159 | Natural-Knee II System | Intermedics Orthopedics | 1995 | 6 |
| −4 | K032522 | Tecres Spacer-K Temporary Knee Prosthesis | Exactech, Inc. | 2004 | — |
| −3 | K050210 | Disposable Cement Spacer Molds for Temporary Knee Prostheses | Biomet, Inc. | 2005 | 8 |
| −2 | K062274 | Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121… | Tecres S.P.A. | 2008 | — |
| −1 | K101356 | Spacer-G and Spacer-K | Tecres S.P.A. | 2011 | — |
| 0 (this device) | K191016 | COPAL exchange G Hip and Knee Spacers | Heraeus Medical GmbH | 2019 | — |
| +1 | K220492 | COPAL exchange G hip spacer | Heraeus Medical GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 KWY? 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 KWY device
- #1 K253357 b-ONE® Bipolar Headscore 11.2 · 1 generation · 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 |
|---|---|---|---|
| * | K101356 | Spacer-G and Spacer-KSummary page 4…60 and 21 CFR 888.3390 Product codes: JWH, KWL and KWY 3. PREDICATE DEVICES • Tecres Hip and Knee Spacers subject of K101356 (including its former versions K062274, K062273 and K031841) K191016 COPAL® exchange G Hip and Knee Spacers === P… | 2011 |
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 |
|---|---|---|---|
| K220492 | COPAL exchange G hip spacer | 2022 | 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 24 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K220492 (Heraeus Medical GmbH, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K101356.
How does its category compare?
All KWY devicesKWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KWY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWY
126in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWY
180in 2025
MAUDE reports naming product code KWY, 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 | — | 25 | 370 |
| 2008 | 3 | 123 | 0 | 900 |
| 2009 | 1 | — | 24 | 961 |
| 2010 | 4 | 187 | 1 | 688 |
| 2011 | 1 | — | 0 | 758 |
| 2012 | 1 | — | 1 | 978 |
| 2013 | 2 | — | 2 | 1,148 |
| 2014 | 1 | — | 0 | 1,055 |
| 2015 | 1 | — | 0 | 1,213 |
| 2016 | 1 | — | 3 | 877 |
| 2017 | 1 | — | 2 | 826 |
| 2018 | 3 | 219 | 1 | 1,380 |
| 2019 | 5 | 126 | 1 | 1,530 |
| 2020 | 1 | — | 0 | 1,259 |
| 2021 | 0 | — | 0 | 276 |
| 2022 | 2 | — | 0 | 208 |
| 2023 | 2 | — | 0 | 178 |
| 2024 | 0 | — | 1 | 209 |
| 2025 | 1 | — | 2 | 180 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
COPAL® exchange G Knee Spacer: COPAL® exchange G knee (polymethylmethacrylate/gentamicin) is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. COPAL® exchange G knee is applied on the femoral condyles and on the tibial plate following removal of the existing implant and radical debridement. The device is intended for use in…
Read the full statement (284 words)
COPAL® exchange G Knee Spacer:
COPAL® exchange G knee (polymethylmethacrylate/gentamicin) is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. COPAL® exchange G knee is applied on the femoral condyles and on the tibial plate following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
COPAL® exchange G knee is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). COPAL® exchange G knee is only indicated for patientswho will consistently use traditional mobility assist devices e.g. crutches, walkers, canes) throughout the implantation period.
COPAL® exchange G Hip Spacer:
COPAL® exchange G hip (polymethylmethacrylate / gentamicin) is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is assigned to be used in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). COPAL® exchange G hip is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, perm etc.). COPAL® exchange G hip is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191016: COPAL exchange G Hip and Knee Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191016
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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