510(k) · Cleared
ClearedHip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osartis GmbH · MBB Bone Cement, Antibiotic
Cleared on Nov 20, 2024 as substantially equivalent to K112470 (Mandell Horwitz Consultants, LLC, 2012) and 2 other predicates after a 237-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Nov 20, 2024
- Review
- 237 days
- Class
- Class II
- Product code
- MBB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K911686 (1991). 46 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet.
- Root · 7 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 6 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 5 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 4 generations backK042021 Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · Recalled
- 3 generations backK060535 Spacer-S Temporary Shoulder SpacerTecres S.P.A. · 2006
- 2 generations backK112983 Spacer-STecres S.P.A. · 2011
- 1 generation backK152267 Remedy® Shoulder SpacerOsteoremedies, LLC · 2015
- This deviceK240856 Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −6 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −4 | K042021 | Exactech Equinoxe Shoulder System | Exactech, Inc. | 2004 | 10 |
| −3 | K060535 | Spacer-S Temporary Shoulder Spacer | Tecres S.P.A. | 2006 | — |
| −2 | K112983 | Spacer-S | Tecres S.P.A. | 2011 | — |
| −1 | K152267 | Remedy® Shoulder Spacer | Osteoremedies, LLC | 2015 | — |
| 0 (this device) | K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds | Osartis GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 6 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 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 MBB? 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 MBB device
- #1 K252443 SpaceFix Shoulder Spacerscore 12.4 · 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 |
|---|---|---|---|
| * | K112470 | 2GC Hip/Knee Modular SpacerSummary page 7…Product Code: MBB Subsequent Product Codes: HSD, KWS Panel: Orthopedic Predicate Device • REMEDY® Hip and Knee Spacer (K112470) – Originally cleared under the trade name, 2GC Hip/Knee Modular Spacer (S.E. 04/05/2012) • Remedy® Shoulder Spacer (… | 2012 |
| * | K152267 | Remedy® Shoulder SpacerSummary page 7…• REMEDY® Hip and Knee Spacer (K112470) – Originally cleared under the trade name, 2GC Hip/Knee Modular Spacer (S.E. 04/05/2012) • Remedy® Shoulder Spacer (K152267, S.E. 12/15/2015) • InterSpace Knee (K181732, S.E. 27/04/2019) Reference Device • Biomet OneStage Hip Spacer Mold K22… | 2015 |
| * | K181732 | InterSpace Knee Extra-Large Size, InterSpace Knee ATSSummary page 7…ally cleared under the trade name, 2GC Hip/Knee Modular Spacer (S.E. 04/05/2012) • Remedy® Shoulder Spacer (K152267, S.E. 12/15/2015) • InterSpace Knee (K181732, S.E. 27/04/2019) Reference Device • Biomet OneStage Hip Spacer Mold K222760 • Biomet OneStage Knee Spacer Mold K2132… | 2019 |
| † | K222760 | StageOne™ Select Hip Cement Spacer Molds | 2022 |
| † | K213287 | StageOne Knee Cement Spacer Molds | 2022 |
| † | K221968 | StageOne™ Shoulder Cement Spacer Molds | 2022 |
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 33 years and passes through 6 companies; a new generation was cleared every 5.3 years on median.
- 7 of the 46 ancestors have a recall of any class.
- 7 other devices also cite its predicate K112470.
How does its category compare?
All MBB devicesMBB Bone Cement, Antibiotic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MBB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBB
106in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBB
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBB
172in 2025
MAUDE reports naming product code MBB, 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 | 1 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 18 |
| 2011 | 0 | — | 0 | 31 |
| 2012 | 0 | — | 0 | 34 |
| 2013 | 0 | — | 2 | 32 |
| 2014 | 1 | — | 0 | 41 |
| 2015 | 1 | — | 0 | 20 |
| 2016 | 2 | — | 0 | 327 |
| 2017 | 1 | — | 0 | 288 |
| 2018 | 0 | — | 0 | 332 |
| 2019 | 2 | — | 0 | 497 |
| 2020 | 1 | — | 0 | 375 |
| 2021 | 1 | — | 0 | 649 |
| 2022 | 3 | 106 | 1 | 275 |
| 2023 | 0 | — | 0 | 262 |
| 2024 | 2 | — | 0 | 212 |
| 2025 | 1 | — | 0 | 172 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
Hip Spacer Molds Hip Spacer Molds with stainless-steel reinforcement stems, centralizers and Hip Head Inserts are indicated for use to mold a temporary hemi-hip spacer for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary hemi-hip spacer is molded using Cemex Genta LV, and inserted into femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants…
Read the full statement (493 words)
Hip Spacer Molds
Hip Spacer Molds with stainless-steel reinforcement stems, centralizers and Hip Head Inserts are indicated for use to mold a temporary hemi-hip spacer for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary hemi-hip spacer is molded using Cemex Genta LV, and inserted into femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).
The temporary hemi-hip spacer made from Hip Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).
Due to the inherent mechanical limitations of the temporary hemi-hip spacer material (Cemex Genta LV) the temporary hemi-hip spacers is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers) throughout the implant period.
Knee Spacer Molds
Femoral Knee Spacer Molds and Tibial Knee Spacer Molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Cemex Genta LV and inserted into the joint space following removal of the existing total knee replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The temporary total knee spacer made from the Femoral Knee Spacer Molds and Tibial Knee Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).
Due to the inherent mechanical limitations of the temporary total knee spacer material (Cemex Genta LV), the temporary total knee spacer is only indicated for patients who will consistently use traditional mobility devices (e.g., crutches, walkers) throughout the implant period.
Shoulder Spacer Molds
Shoulder Spacer Molds with stainless-steel reinforcement stems, centralizers and Shoulder Head Inserts are indicated for use to mold a temporary hemi-shoulder spacer for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary hemi-shoulder spacer is molded using Cemex Genta LV, and inserted into femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).
The temporary hemi-shoulder spacer made from Shoulder Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).
Due to the inherent mechanical limitations of hemi-shoulder prothesis material (Cemex Genta LV) the temporary hemi-shoulder prothesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240856 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240856: Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240856
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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