510(k) · Cleared
ClearedSpaceFlex Knee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G21, S.R.L. · MBB Bone Cement, Antibiotic
Cleared on Jun 9, 2019 as substantially equivalent to K161273 (Biomet, Inc., 2017) and 2 other predicates after a 125-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.
- Decided
- Jun 9, 2019
- Review
- 125 days
- Class
- Class II
- Product code
- MBB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K936159 (1995). 15 ancestors in all, the oldest P810020 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK936159 Natural-Knee II SystemIntermedics Orthopedics · 1995 · Recalled
- 5 generations backK032522 Tecres Spacer-K Temporary Knee ProsthesisExactech, Inc. · 2004
- 4 generations backK050210 Disposable Cement Spacer Molds for Temporary Knee ProsthesesBiomet, Inc. · 2005 · Recalled
- 3 generations backK062274 Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021…Tecres S.P.A. · 2008
- 2 generations backK101356 Spacer-G and Spacer-KTecres S.P.A. · 2011
- 1 generation backK112470 2GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012
- This deviceK190216 SpaceFlex KneeG21, S.R.L. · 2019
- Descendant · cites it directly · 0 of its ownK201960 SpaceFlex Knee - 80mm SizeG21, S.R.L. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201960SpaceFlex Knee - 80mm SizeG21, S.R.L. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K936159 | Natural-Knee II System | Intermedics Orthopedics | 1995 | 6 |
| −5 | K032522 | Tecres Spacer-K Temporary Knee Prosthesis | Exactech, Inc. | 2004 | — |
| −4 | K050210 | Disposable Cement Spacer Molds for Temporary Knee Prostheses | Biomet, Inc. | 2005 | 8 |
| −3 | K062274 | Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121… | Tecres S.P.A. | 2008 | — |
| −2 | K101356 | Spacer-G and Spacer-K | Tecres S.P.A. | 2011 | — |
| −1 | K112470 | 2GC Hip/Knee Modular Spacer | Mandell Horwitz Consultants, LLC | 2012 | — |
| 0 (this device) | K190216 | SpaceFlex Knee | G21, S.R.L. | 2019 | — |
| +1 | K201960 | SpaceFlex Knee - 80mm Size | G21, S.R.L. | 2020 | — |
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 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K161273 | StageOne Disposable Cement Spacer Molds for Temporary Knee ProsthesisSummary page 4…MBB, JWH III. PREDICATE DEVICES Primary Predicate: StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis, Biomet, Inc. (K161273) Additional Predicates: SPACER-K Temporary Knee Prosthesis, Tecres S.p.A. (K062274), OsteoRemedies Knee Modula… | 2017 |
| * | K062274 | Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321Summary page 4…le Cement Spacer Molds for Temporary Knee Prosthesis, Biomet, Inc. (K161273) Additional Predicates: SPACER-K Temporary Knee Prosthesis, Tecres S.p.A. (K062274), OsteoRemedies Knee Modular Spacer (K112470, filed under Garventis LLC Ronald Reagan and International Trade C… | 2008 |
| * | K112470 | 2GC Hip/Knee Modular SpacerSummary page 4…Biomet, Inc. (K161273) Additional Predicates: SPACER-K Temporary Knee Prosthesis, Tecres S.p.A. (K062274), OsteoRemedies Knee Modular Spacer (K112470, filed under Garventis LLC Ronald Reagan and International Trade Center)… | 2012 |
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 |
|---|---|---|---|
| K201960 | SpaceFlex Knee - 80mm Size | 2020 | 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 6 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 15 ancestors have a recall of any class.
- Of its descendants, K201960 (G21, S.R.L., 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K161273.
How does its category compare?
All MBB devicesMBB Bone Cement, Antibiotic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 (G3A Bone Cement), 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190216 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190216: SpaceFlex Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190216
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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