510(k) · Decided

Decided

Optimesh 500E Cement Restrictor

K033953510(k) TraditionalDecided Jul 6, 2004197-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

Spineology, Inc. · JDK Prosthesis, Hip, Cement Restrictor

Cleared on Jul 6, 2004 as substantially equivalent to K020836 (Signus Medical, LLC, 2002) and 2 other predicates after a 197-day review. Its family tree reaches back 4 generations to 2001.

Decided: Jul 6, 2004
Review: 197 days
Class: Class II
Product code: JDK
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K003718 (2001). 12 ancestors in all, the oldest K900138 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK003718 Titanium Cement Restrictor (TCR)Medtronic Sofamor Danek, Inc. · 2001
3 generations backK013014 Block Cement Restrictor (CR) - TitaniumMedtronic Sofamor Danek, Inc. · 2001
2 generations backK013663 Cement RestrictorMedtronic Sofamor Danek, Inc. · 2001
1 generation backK020836 Rabea Cement RestrictorSignus Medical, LLC · 2002
This deviceK033953 Optimesh 500E Cement RestrictorSpineology, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K003718	Titanium Cement Restrictor (TCR)	Medtronic Sofamor Danek, Inc.	2001	—
−3	K013014	Block Cement Restrictor (CR) - Titanium	Medtronic Sofamor Danek, Inc.	2001	—
−2	K013663	Cement Restrictor	Medtronic Sofamor Danek, Inc.	2001	—
−1	K020836	Rabea Cement Restrictor	Signus Medical, LLC	2002	—
0 (this device)	K033953	Optimesh 500E Cement Restrictor	Spineology, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1991	1	0
1993	1	0
1999	1	0
2001	3	0
2003	1	0

FIG. 1 — Lineage of K033953, 2001–2004Source: 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? (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	Applicant	Decided	Recalls
*	K020836	Rabea Cement Restrictor Summary page 1 …JDK Predicate Devices The subject device is substantially equivalent to similar previously cleared predicate devices, RABEA Cement Restrictor, K020836, ImproVise Absorbable Cement Flow Restrictor, KOI 1943 and OptiMesh, K014200. Device Description OptiMesh 500E is an implantable…	Signus Medical, LLC	2002	—
*	K011943	Impro Vise Absorbable Cement Flow Restrictor	Kensey Nash Corp.	2001	—
*	K014200	Optimesh Summary page 1 …ntially equivalent to similar previously cleared predicate devices, RABEA Cement Restrictor, K020836, ImproVise Absorbable Cement Flow Restrictor, KOI 1943 and OptiMesh, K014200. Device Description OptiMesh 500E is an implantable PET device indicated for use as a cement restrictor in the femur and tibia.…	Spineology, Inc.	2003	—

Also cleared against K020836: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 3 years and passes through 3 companies; a new generation was cleared every 8 months on median.
None of the 12 ancestors has a recall.
2 other devices also cite its predicate K020836.

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?

OptiMesh 500E is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal or tibial plateau in hip stem and total knee replacement.

OptiMesh 500E is not intended for use in spinal indications.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033953 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033953: Optimesh 500E Cement Restrictor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033953

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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