510(k) · Cleared
ClearedRPX Titanium Cemnt Restrictor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Spine-Tech · JDK Prosthesis, Hip, Cement Restrictor
Cleared on May 2, 2002 as substantially equivalent to K990345 (Signus Medizintechnik GmbH, 1999) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1990. 33 later devices descend from it.
- Decided
- May 2, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- JDK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K900138 (1990). 5 ancestors in all. 33 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK900138 Motech Titanium Surgical MeshBiedermann Motech GmbH · 1990
- 1 generation backK990345 Rabea Device, Model PxxxxxxSignus Medizintechnik GmbH · 1999
- This deviceK020344 RPX Titanium Cemnt RestrictorSulzer Spine-Tech · 2002
- Descendant · cites it directly · 32 of its ownK022615 Centerpulse, Spine-Tech Division Cement RestrictorCenterpulse Spine-Tech, Inc. · 2002
- Descendant · 2 generations on · 31 of its ownK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- Descendant · 3 generations on · 29 of its ownK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- Descendant · 3 generations on · 16 of its ownK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled
- Descendant · 3 generations on · 15 of its ownK111056 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · Recalled
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K022615Centerpulse, Spine-Tech Division Cement RestrictorCenterpulse Spine-Tech, Inc. · 2002 · cites it directly32descendants
- K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010 · 2 generations on31descendants
- K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010 · 3 generations on29descendants
- K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · 3 generations on16descendants
- K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900138 | Motech Titanium Surgical Mesh | Biedermann Motech GmbH | 1990 | — |
| −1 | K990345 | Rabea Device, Model Pxxxxxx | Signus Medizintechnik GmbH | 1999 | — |
| 0 (this device) | K020344 | RPX Titanium Cemnt Restrictor | Sulzer Spine-Tech | 2002 | — |
| +1 | K022615 | Centerpulse, Spine-Tech Division Cement Restrictor | Centerpulse Spine-Tech, Inc. | 2002 | — |
| +2 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| +3 | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System) | N.M.B. Medical Applications, Ltd. | 2010 | — |
| +3 | K102369 | Piccolo Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2011 | 1 |
| +3 | K111056 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2011 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 JDK? 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 JDK device
- #1 K210062 Mectaplug PE IIscore 5.0 · 14 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K990345 | Rabea Device, Model PxxxxxxSummary page 1…l Plug, Cement Restrictor (per 21 CFR Part 878.3300) Class II (per 21 CFR Part 878.3300) Panel —Orthopedic SIGNUS Medizintechnik, GmbH RABEA Cement Restrictor Device (K990345) Medtronic Sofamor Danek BLOCK CR Cement Restrictor (K013014) The RPX™ Cement Restrictor Device is a hollow, tapered block that… | 1999 |
| * | K013014 | Block Cement Restrictor (CR) - TitaniumSummary page 1…I (per 21 CFR Part 878.3300) Panel —Orthopedic SIGNUS Medizintechnik, GmbH RABEA Cement Restrictor Device (K990345) Medtronic Sofamor Danek BLOCK CR Cement Restrictor (K013014) The RPX™ Cement Restrictor Device is a hollow, tapered block that is titanium. This device is intended to be used in conjunctio… | 2001 |
What descends from it? (33)
See all 331 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022615 | Centerpulse, Spine-Tech Division Cement Restrictor | 2002 | 32 |
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 12 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K022615 (Centerpulse Spine-Tech, Inc., 2002) has gone furthest, with 32 descendants of its own.
- 5 other devices also cite its predicate K990345.
How does its category compare?
All JDK devicesJDK Prosthesis, Hip, Cement Restrictor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDK
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JDK
Too few JDK 510(k)s in any year since 2007 to give a median.
Recalls per year · JDK
5in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDK
6in 2025
MAUDE reports naming product code JDK, 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 | — | 6 | 3 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 5 | 3 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sulzer Spine-Tech RPX™ Cement Restrictor is intended for use as a cement
restrictor in orthopedic surgeries such as those involving the femoral canal and
tibial plateau in hip stem and total knee replacement.
The RPX™ Cement Restrictor is not intended for any spinal indications. The
safety and effectiveness of this device when implanted in the spine have not been
established.
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/K020344 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020344: RPX Titanium Cemnt Restrictor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020344
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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