510(k) · Decided

Decided

Block Cement Restrictor (CR) - Titanium

K013014510(k) SpecialDecided Oct 4, 200127-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

Medtronic Sofamor Danek, Inc. · JDK Prosthesis, Hip, Cement Restrictor

Cleared on Oct 4, 2001 as substantially equivalent to K003718 (Medtronic Sofamor Danek, Inc., 2001) after a 27-day review. Its family tree reaches back 1 generation to 2001. 47 later devices descend from it.

Decided: Oct 4, 2001
Review: 27 days
Class: Class II
Product code: JDK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003718 (2001). 47 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK003718 Titanium Cement Restrictor (TCR)Medtronic Sofamor Danek, Inc. · 2001
This deviceK013014 Block Cement Restrictor (CR) - TitaniumMedtronic Sofamor Danek, Inc. · 2001
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 47 descendants. See all descendants

Descendants cleared per year

2001high 5 (2002) · low 0 (2007)2026

Most influential descendants

Showing 5 of 47 · 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	K003718	Titanium Cement Restrictor (TCR)	Medtronic Sofamor Danek, Inc.	2001	—
0 (this device)	K013014	Block Cement Restrictor (CR) - Titanium	Medtronic Sofamor Danek, Inc.	2001	—
+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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	5	0
2003	2	0
2004	2	0
2005	4	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 K013014, 2001–2026Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K003718	Titanium Cement Restrictor (TCR) Summary page 1 …V. Substantial Equivalence: The BLOCK CR - TITANIUM was demonstrated to be substantially equivalent to previously cleared devices such as TITANIUM CEMENT RESTRICTOR (K003718). A Design Review for the device was provided in this submission. & { DEPARTMENT OF HEALTH & HUMAN SERVICES Publ…	Medtronic Sofamor Danek, Inc.	2001	—

Also cleared against K003718: 5 other devices →

What descends from it? (47)

See all 47

4 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
K013663	Cement Restrictor	Medtronic Sofamor Danek, Inc.	2001	8
K021719	Fortitude Cement Restrictor	Spinal Concepts, Inc.	2002	6
K051607	Novaspine Cement Restrictor NSCR	Novaspine, LLC	2005	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?

Its one ancestor has no recall.
Of its descendants, K020344 (Sulzer Spine-Tech, 2002) has gone furthest, with 33 descendants of its own.
5 other devices also cite its predicate K003718.

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 Medtronic Sofamor Danek Block Cement Restrictor (CR) — Titanium is intended for use as a cement restrictor in orthopedic surgeries in the femur and tibia in hip and knee replacement.

The Block CR-Titanium is NOT intended for any spinal indications.

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/K013014 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013014: Block Cement Restrictor (CR) - Titanium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013014

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026