510(k) · Cleared
Recalled · Class II · 2020StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · MBB Bone Cement, Antibiotic
Cleared on Jan 25, 2017 as substantially equivalent to K050210 (Biomet, Inc., 2005) after a 265-day review. Its family tree reaches back 3 generations to 1995. 3 later devices descend from it. It has been recalled 8 times.
- Decided
- Jan 25, 2017
- Review
- 265 days
- Class
- Class II
- Product code
- MBB
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 3 generations to K936159 (1995). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK936159 Natural-Knee II SystemIntermedics Orthopedics · 1995 · Recalled
- 2 generations backK032522 Tecres Spacer-K Temporary Knee ProsthesisExactech, Inc. · 2004
- 1 generation backK050210 Disposable Cement Spacer Molds for Temporary Knee ProsthesesBiomet, Inc. · 2005 · Recalled
- This deviceK161273 StageOne Disposable Cement Spacer Molds for Temporary Knee ProsthesisBiomet, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK190216 SpaceFlex KneeG21, S.R.L. · 2019
- Descendant · cites it directly · 0 of its ownK213287 StageOne Knee Cement Spacer MoldsBiomet, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK201960 SpaceFlex Knee - 80mm SizeG21, S.R.L. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K936159 | Natural-Knee II System | Intermedics Orthopedics | 1995 | 6 |
| −2 | K032522 | Tecres Spacer-K Temporary Knee Prosthesis | Exactech, Inc. | 2004 | — |
| −1 | K050210 | Disposable Cement Spacer Molds for Temporary Knee Prostheses | Biomet, Inc. | 2005 | 8 |
| 0 (this device) | K161273 | StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis | Biomet, Inc. | 2017 | — |
| +1 | K190216 | SpaceFlex Knee | G21, S.R.L. | 2019 | — |
| +1 | K213287 | StageOne Knee Cement Spacer Molds | Biomet, Inc. | 2022 | — |
| +1 | K201960 | SpaceFlex Knee - 80mm Size | G21, S.R.L. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K050210 | Disposable Cement Spacer Molds for Temporary Knee ProsthesesSummary page 4…/polymer semi-constrained cemented prosthesis (21 CFR 888.3560) Legally marketed devices to which substantial equivalence is claimed: x K050210 – Disposable Cement Spacer Molds for Temporary Knee Prosthesis Device Description The disposable cement spacer molds (femoral an… | 2005 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 26, 2020 | Class II | Z-1664-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1669-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1663-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1665-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1667-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1662-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1668-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1666-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K190216 (G21, S.R.L., 2019) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K050210.
How does its category compare?
All MBB devicesMBB Bone Cement, Antibiotic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Disposable cement spacer molds are 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 prosthesis 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 and Refobacin® Bone Cement R), the molded temporary prosthesis 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/K161273 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161273: StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161273
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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