510(k) · Decided

Decided

Rabea Device, Model Pxxxxxx

K990345510(k) TraditionalDecided Jul 30, 1999176-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Signus Medizintechnik GmbH · JDK Prosthesis, Hip, Cement Restrictor

Cleared on Jul 30, 1999 as substantially equivalent to K914406 (Osteonics Corp., 1991) and 1 other predicate after a 176-day review. Its family tree reaches back 1 generation to 1990. 46 later devices descend from it.

Decided: Jul 30, 1999
Review: 176 days
Class: Class II
Product code: JDK
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K900138 (1990). 2 ancestors in all. 46 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK900138 Motech Titanium Surgical MeshBiedermann Motech GmbH · 1990
This deviceK990345 Rabea Device, Model PxxxxxxSignus Medizintechnik GmbH · 1999
Descendant · cites it directly · 33 of its ownK020344 RPX Titanium Cemnt RestrictorSulzer Spine-Tech · 2002
Descendant · 2 generations on · 32 of its ownK022615 Centerpulse, Spine-Tech Division Cement RestrictorCenterpulse Spine-Tech, Inc. · 2002
Descendant · 3 generations on · 31 of its ownK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
Descendant · 4 generations on · 29 of its ownK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
Descendant · 4 generations on · 16 of its ownK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled

Showing 5 of 46 descendants. See all descendants

Descendants cleared per year

2001high 5 (2002) · low 0 (2007)2026

Most influential descendants

Showing 5 of 46 · See all

K020344RPX Titanium Cemnt RestrictorSulzer Spine-Tech · 2002 · cites it directly33descendants
K022615Centerpulse, Spine-Tech Division Cement RestrictorCenterpulse Spine-Tech, Inc. · 2002 · 2 generations on32descendants
K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010 · 3 generations on31descendants
K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010 · 4 generations on29descendants
K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · 4 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K900138	Motech Titanium Surgical Mesh	Biedermann Motech GmbH	1990	—
0 (this device)	K990345	Rabea Device, Model Pxxxxxx	Signus Medizintechnik GmbH	1999	—
+1	K020344	RPX Titanium Cemnt Restrictor	Sulzer Spine-Tech	2002	—
+2	K022615	Centerpulse, Spine-Tech Division Cement Restrictor	Centerpulse Spine-Tech, Inc.	2002	—
+3	K091425	Quantum M Composite Nailing System	N.M.B. Medical Applications, Ltd.	2010	—
+4	K100497	Quantum IM Composite Nailing System (Quantum Nailing System)	N.M.B. Medical Applications, Ltd.	2010	—
+4	K102369	Piccolo Composite Nailing System	N.M.B. Medical Applications, Ltd.	2011	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0
2002	5	0
2003	1	0
2004	2	0
2005	3	0
2006	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

FIG. 1 — Lineage of K990345, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K914406	PT II Distal Cement Spacer Summary page 1 …II, 21 CFR 878.3300 JDK The RABEA™ Cement Restrictor Device is substantially equivalent to the Osteonics PTII Cement Spacer which was cleared via premarket notification K914406 on December 20, 1991, and the Motech Surgical Mesh which was cleared for use as a cement restrictor via premarket notification K9…	Osteonics Corp.	1991	—
*	K900138	Motech Titanium Surgical Mesh Summary page 1 …cleared via premarket notification K914406 on December 20, 1991, and the Motech Surgical Mesh which was cleared for use as a cement restrictor via premarket notification K900138 on March 20, 1990. The RABEA™ Cement Restrictor Device is a hollow, titanium, rounded rectangular frame with fenestrated surface…	Biedermann Motech GmbH	1990	—

Also cleared against K914406: 3 other devices →

What descends from it? (46)

See all 46

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K020344	RPX Titanium Cemnt Restrictor	Sulzer Spine-Tech	2002	33
K021719	Fortitude Cement Restrictor	Spinal Concepts, Inc.	2002	6
K020836	Rabea Cement Restrictor	Signus Medical, LLC	2002	4
K021788	NBD Cement Restrictor Device	New Business Development, LLC	2002	0
K012462	Theken Large Cement Restrictor	Theken Surgical,Llc	2001	0
K012278	Theken Small Cement Restrictor	Theken Surgical,Llc	2001	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?

None of the 2 ancestors has a recall.
Of its descendants, K020344 (Sulzer Spine-Tech, 2002) has gone furthest, with 33 descendants of its own.
3 other devices also cite its predicate K914406.

How does its category compare?

All JDK devices

JDK Prosthesis, Hip, Cement Restrictor: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDK

1in 2021

2007high 1 (2021) · low 0 (2007)2026

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

2007high 6 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDK

6in 2025

2007high 13 (2019) · low 0 (2017)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 RABEAT Cement Restrictor Device is intended for usc as a cement restrictor in orthopedic surgeries such as those involving the fernuial canal end tibial plateau in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgerics.

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/K990345 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990345: Rabea Device, Model Pxxxxxx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990345

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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