510(k) Report

510(k) · Cleared

Cleared

Novaspine Cement Restrictor NSCR

K051607510(k) TraditionalCleared Oct 7, 2005112-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

Novaspine, LLC · JDK Prosthesis, Hip, Cement Restrictor

Cleared on Oct 7, 2005 as substantially equivalent to K003718 (Medtronic Sofamor Danek, Inc., 2001) and 6 other predicates after a 112-day review. Its family tree reaches back 4 generations to 1990.

Decided
Oct 7, 2005
Review
112 days
Class
Class II
Product code
JDK
Recalls
None
Predicates
8

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

Other ancestors, by year cleared 2002: 1 other ancestor2001: 6 other ancestors1991: 1 other ancestorK900138 · Motech Titanium Surgical Mesh · Biedermann Motech GmbH · 1990K990345 · Rabea Device, Model Pxxxxxx · Signus Medizintechnik GmbH · 1999K021719 · Fortitude Cement Restrictor · Spinal Concepts, Inc. · 2002K031837 · Modification to Fortitude Cement Restrictor · Spinal Concepts, Inc. · 20031990199520002005
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor K031837 · Modification to Fortitude Cement Restrictor · Spinal Concepts, Inc. · 2003K021719 · Fortitude Cement Restrictor · Spinal Concepts, Inc. · 2002K990345 · Rabea Device, Model Pxxxxxx · Signus Medizintechnik GmbH · 1999K900138 · Motech Titanium Surgical Mesh · Biedermann Motech GmbH · 19900
  1. Root · 4 generations backK900138 Motech Titanium Surgical MeshBiedermann Motech GmbH · 1990
  2. 3 generations backK990345 Rabea Device, Model PxxxxxxSignus Medizintechnik GmbH · 1999
  3. 2 generations backK021719 Fortitude Cement RestrictorSpinal Concepts, Inc. · 2002
  4. 1 generation backK031837 Modification to Fortitude Cement RestrictorSpinal Concepts, Inc. · 2003
  5. This deviceK051607 Novaspine Cement Restrictor NSCRNovaspine, LLC · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K900138Motech Titanium Surgical MeshBiedermann Motech GmbH1990—
−3K990345Rabea Device, Model PxxxxxxSignus Medizintechnik GmbH1999—
−2K021719Fortitude Cement RestrictorSpinal Concepts, Inc.2002—
−1K031837Modification to Fortitude Cement RestrictorSpinal Concepts, Inc.2003—
0 (this device)K051607Novaspine Cement Restrictor NSCRNovaspine, LLC2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
200160
200210
FIG. 1 — Lineage of K051607, 1990–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K210062 Mectaplug PE IIscore 5.0 · 14 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (8)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K003718Titanium Cement Restrictor (TCR)
Summary page 1
…ss I1 Device product Code JDK Substantial Equivalency Medtronics Sofamore Danek USA, Inc.: (K003718, K011443, K012255, K013014) Spinal Concepts, Inc.:…
Medtronic Sofamor Danek, Inc.2001—
*K011443Threaded Cement Restrictor (CR) Titanium
Summary page 1
…vice product Code JDK Substantial Equivalency Medtronics Sofamore Danek USA, Inc.: (K003718, K011443, K012255, K013014) Spinal Concepts, Inc.: (K0222…
Medtronic Sofamor Danek USA, Inc.2001—
*K012255Medtronic Sofamor Danek Cement Restrictor
Summary page 1
…uct Code JDK Substantial Equivalency Medtronics Sofamore Danek USA, Inc.: (K003718, K011443, K012255, K013014) Spinal Concepts, Inc.: (K022218, K0217…
Medtronic Sofamor Danek, Inc.2001—
*K013014Block Cement Restrictor (CR) - Titanium
Summary page 1
…JDK Substantial Equivalency Medtronics Sofamore Danek USA, Inc.: (K003718, K011443, K012255, K013014) Spinal Concepts, Inc.: (K022218, K021719, K0318…
Medtronic Sofamor Danek, Inc.2001—
*K022218Cadence Cement Restrictor
Summary page 1
…(K003718, K011443, K012255, K013014) Spinal Concepts, Inc.: (K022218, K021719, K031837, K03118) K051607…
Spinal Concepts, Inc.2002—
*K021719Fortitude Cement Restrictor
Summary page 1
…(K003718, K011443, K012255, K013014) Spinal Concepts, Inc.: (K022218, K021719, K031837, K03118) K051607…
Spinal Concepts, Inc.2002—
*K031837Modification to Fortitude Cement Restrictor
Summary page 1
…(K003718, K011443, K012255, K013014) Spinal Concepts, Inc.: (K022218, K021719, K031837, K03118) K051607…
Spinal Concepts, Inc.2003—
Kept off the family treeK03118Spinal Concepts, Inc.
Number could not be read
Summary page 1
…(K003718, K011443, K012255, K013014) Spinal Concepts, Inc.: (K022218, K021719, K031837, K03118) K051607…

Also cleared against K003718: 5 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 15 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
  • None of the 12 ancestors has a recall.
  • 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

2021: 1
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

2007: 62011: 5
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

2007: 32008: 52009: 12010: 22011: 32012: 12013: 32014: 22015: 72016: 22018: 12019: 132020: 42021: 32022: 42023: 72024: 52025: 6
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—63
20080—05
20090—01
20100—02
20110—53
20120—01
20130—03
20140—02
20150—07
20160—02
20170—00
20180—01
20190—013
20200—04
20211—03
20220—04
20230—07
20240—05
20250—06
20260—0—

What is it indicated for?

The NovaSpine Cement Restrictor device 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 NovaSpine Cement Restrictoris NOT intended for any spinal indications.

Indications for use as stated in the FDA summary.

Also cleared against K003718

5 other devices cite the same predicate.

  • K022218Cadence Cement RestrictorSpinal Concepts, Inc. · 2002
  • K012462Theken Large Cement RestrictorTheken Surgical,Llc · 2001
  • K013014Block Cement Restrictor (CR) - TitaniumMedtronic Sofamor Danek, Inc. · 2001
  • K011715Macropore IB Resorbable PlugMacropore Biosurgery, Inc. · 2001
  • K012255Medtronic Sofamor Danek Cement RestrictorMedtronic Sofamor Danek, Inc. · 2001

More from Novaspine, LLC

3 FDA decisions under this applicant name. See the company

  • K062456Novaspine Powered Suction Pump Pro-1Novaspine, LLC · 2006
  • K061133Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30SNovaspine, LLC · 2006

Recent decisions in JDK

The JDK category page

  • K210062Mectaplug PE IIMedacta International S.A. · 2021
  • K061465Kmi Cement Restrictor ImplantKinetikos Medical, Inc. · 2006
  • K061698Modification to Life Spine Cement RestrictorLife Spine · 2006
  • K060247Life Spine Cement RestrictorLife Spine · 2006
  • K060132Spinal Usa Cement Restrictor SystemSpinal USA · 2006

https://510kreport.com/device/K051607 · printed Nov 4, 2026

Cite this page

510(k) Report. “K051607: Novaspine Cement Restrictor NSCR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051607

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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