510(k) Report

510(k) · Decided

Decided

Interbody Innovations Cement Restrictor

K051371510(k) TraditionalDecided Dec 6, 2005194-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

Interbody Innovations, Llp · JDK Prosthesis, Hip, Cement Restrictor

Cleared on Dec 6, 2005 as substantially equivalent to K031837 (Spinal Concepts, Inc., 2003) and 2 other predicates after a 194-day review. Its family tree reaches back 4 generations to 2001.

Decided
Dec 6, 2005
Review
194 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.

Other ancestors, by year cleared 2003: 2 other ancestors2002: 1 other ancestor1999: 1 other ancestor2001: 2 other ancestors1991: 1 other ancestor1990: 1 other ancestorK003718 · Titanium Cement Restrictor (TCR) · Medtronic Sofamor Danek, Inc. · 2001×2: 2 generations cleared close together, K013014 (2001), K013663 (2001) K020836 · Rabea Cement Restrictor · Signus Medical, LLC · 20021990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 4 other ancestors K020836 · Rabea Cement Restrictor · Signus Medical, LLC · 2002K013663 · Cement Restrictor · Medtronic Sofamor Danek, Inc. · 2001K013014 · Block Cement Restrictor (CR) - Titanium · Medtronic Sofamor Danek, Inc. · 2001K003718 · Titanium Cement Restrictor (TCR) · Medtronic Sofamor Danek, Inc. · 20010
  1. Root · 4 generations backK003718 Titanium Cement Restrictor (TCR)Medtronic Sofamor Danek, Inc. · 2001
  2. 3 generations backK013014 Block Cement Restrictor (CR) - TitaniumMedtronic Sofamor Danek, Inc. · 2001
  3. 2 generations backK013663 Cement RestrictorMedtronic Sofamor Danek, Inc. · 2001
  4. 1 generation backK020836 Rabea Cement RestrictorSignus Medical, LLC · 2002
  5. This deviceK051371 Interbody Innovations Cement RestrictorInterbody Innovations, Llp · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K003718Titanium Cement Restrictor (TCR)Medtronic Sofamor Danek, Inc.2001—
−3K013014Block Cement Restrictor (CR) - TitaniumMedtronic Sofamor Danek, Inc.2001—
−2K013663Cement RestrictorMedtronic Sofamor Danek, Inc.2001—
−1K020836Rabea Cement RestrictorSignus Medical, LLC2002—
0 (this device)K051371Interbody Innovations Cement RestrictorInterbody Innovations, Llp2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199110
199910
200120
200210
200320
FIG. 1 — Lineage of K051371, 2001–2005Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K031837Modification to Fortitude Cement Restrictor
Summary page 1
…3300 Product Code: JDK Predicate Device: This device is substantially equivalent to the following predicate devices: Fortitude Cement Restrictor, marketed under K031837 FIDJI Large Cement Restrictor, marketed under K030871 RABEA Cement Restrictor, marketed under K020836 Interbody I…
Spinal Concepts, Inc.2003—
*K030871Fidji Large Cement Restrictor
Summary page 1
…antially equivalent to the following predicate devices: Fortitude Cement Restrictor, marketed under K031837 FIDJI Large Cement Restrictor, marketed under K030871 RABEA Cement Restrictor, marketed under K020836 Interbody Innovations Cement Restrictors and predicated devices listed ab…
Spine Next SA2003—
*K020836Rabea Cement Restrictor
Summary page 1
…Fortitude Cement Restrictor, marketed under K031837 FIDJI Large Cement Restrictor, marketed under K030871 RABEA Cement Restrictor, marketed under K020836 Interbody Innovations Cement Restrictors and predicated devices listed above, are devices that are used to occlude the medullary…
Signus Medical, LLC2002—

Also cleared against K031837: 3 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 4 years and passes through 3 companies; a new generation was cleared every 8 months on median.
  • None of the 12 ancestors has a recall.
  • 3 other devices also cite its predicate K031837.

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?

This device is intended for use in conjunction with Standard PMMA cement. The Interbody Innovations Cement Restrictors are designed to occlude the medullar canal before the introduction of PMMA, in total hip or knee replacement.

This device is not intended for use in spine applications. The safety and effectiveness have not been established when implanted into the spine.

Indications for use as stated in the FDA summary.

Also cleared against K031837

3 other devices cite the same predicate.

  • K051607Novaspine Cement Restrictor NSCRNovaspine, LLC · 2005
  • K052367Scient'x Cement RestrictorScient'X · 2005
  • K041583Peek Cement Restrictor X-BoxInnovasis, Inc. · 2004

More from Interbody Innovations, Llp

4 FDA decisions under this applicant name. See the company

  • K081614Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar CagesInterbody Innovations, Llp · 2008
  • K073105Peek Spinal SpheresInterbody Innovations, Llp · 2008
  • K062992Spinal SpheresInterbody Innovations, Llp · 2007

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/K051371 · printed Nov 5, 2026

Cite this page

510(k) Report. “K051371: Interbody Innovations Cement Restrictor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051371

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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