510(k) · Cleared
ClearedSpacer-G Temporary Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tecres S.P.A. · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on May 22, 2008 as substantially equivalent to K031841 (Exactech, Inc., 2004) and 2 other predicates after a 654-day review. Its family tree reaches back 3 generations to 1984. 20 later devices descend from it.
- Decided
- May 22, 2008
- Review
- 654 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to P810020 (1984). 7 ancestors in all. 20 later devices descend from it, 1 citing it directly.
- Root · 3 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- 2 generations backK030086 Palacos R Bone Cement with GentamicinBiomet, Inc. · 2003
- 1 generation backK051532 Cobalt G HV Bone CementBiomet, Inc. · 2005
- This deviceK062273 Spacer-G Temporary Hip ProsthesisTecres S.P.A. · 2008
- Descendant · cites it directly · 19 of its ownK101356 Spacer-G and Spacer-KTecres S.P.A. · 2011
- Descendant · 2 generations on · 16 of its ownK112470 2GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012
- Descendant · 3 generations on · 5 of its ownK183017 Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019
- Descendant · 3 generations on · 5 of its ownK173967 Remedy Acetabular CupOsteoremedies, LLC · 2018
- Descendant · 4 generations on · 4 of its ownK191981 REMEDY Acetabular CupOsteoremedies, LLC · 2019
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K101356Spacer-G and Spacer-KTecres S.P.A. · 2011 · cites it directly19descendants
- K1124702GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012 · 2 generations on16descendants
- K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019 · 3 generations on5descendants
- K173967Remedy Acetabular CupOsteoremedies, LLC · 2018 · 3 generations on5descendants
- K191981REMEDY Acetabular CupOsteoremedies, LLC · 2019 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P810020 | Palacos R Bone Cement | Smith & Nephew Richards, Inc. | 1984 | 1 |
| −2 | K030086 | Palacos R Bone Cement with Gentamicin | Biomet, Inc. | 2003 | — |
| −1 | K051532 | Cobalt G HV Bone Cement | Biomet, Inc. | 2005 | — |
| 0 (this device) | K062273 | Spacer-G Temporary Hip Prosthesis | Tecres S.P.A. | 2008 | — |
| +1 | K101356 | Spacer-G and Spacer-K | Tecres S.P.A. | 2011 | — |
| +2 | K112470 | 2GC Hip/Knee Modular Spacer | Mandell Horwitz Consultants, LLC | 2012 | — |
| +3 | K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | Osteoremedies, LLC | 2019 | — |
| +3 | K173967 | Remedy Acetabular Cup | Osteoremedies, LLC | 2018 | — |
| +4 | K191981 | REMEDY Acetabular Cup | Osteoremedies, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 KWL? 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 KWL device
- #1 K253675 OsteoRemedies Hip Spacer Systemscore 16.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K031841 | Spacer G Temporary Hip ProsthesisSummary page 2…esign, incorporates the same materials, has equivalent performance and mechanical characteristics, and has the same shelf and packaging as the predicate Spacer-G device (K031841). Additionally, the modified Spacer-G device has a similar gentamicin release profile as that of the predicate Biomet Stage One D… | 2004 |
| * | K052990 | Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement…Summary page 2…ce has a similar gentamicin release profile as that of the predicate Biomet Stage One Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement Stem (K052990) when used with predicate Biomet Cobalt G HV Bone Cement (KO51532).… | 2005 |
| * | K051532 | Cobalt G HV Bone Cement | 2005 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101356 | Spacer-G and Spacer-K | 2011 | 19 |
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 3 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K101356 (Tecres S.P.A., 2011) has gone furthest, with 19 descendants of its own.
- 4 other devices also cite its predicate K031841.
How does its category compare?
All KWL devicesKWL Prosthesis, Hip, Hemi-, Femoral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KWL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWL
32in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWL
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWL
29in 2025
MAUDE reports naming product code KWL, 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 | 2 | — | 36 | 11 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 2 | 21 |
| 2010 | 0 | — | 0 | 55 |
| 2011 | 2 | — | 0 | 51 |
| 2012 | 1 | — | 0 | 62 |
| 2013 | 0 | — | 0 | 89 |
| 2014 | 0 | — | 0 | 107 |
| 2015 | 1 | — | 1 | 223 |
| 2016 | 0 | — | 0 | 210 |
| 2017 | 0 | — | 2 | 347 |
| 2018 | 2 | — | 0 | 294 |
| 2019 | 1 | — | 0 | 415 |
| 2020 | 1 | — | 0 | 270 |
| 2021 | 0 | — | 0 | 107 |
| 2022 | 1 | — | 0 | 99 |
| 2023 | 0 | — | 0 | 48 |
| 2024 | 1 | — | 0 | 143 |
| 2025 | 3 | 32 | 0 | 29 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Spacer-G is indicated for temporary use (maximum 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 femoral and acetabular implants and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard…
Read the full statement (104 words)
Spacer-G is indicated for temporary use (maximum 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 femoral and acetabular implants and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
Spacer-G 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.).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062273 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062273: Spacer-G Temporary Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062273
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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