510(k) · Decided
DecidedPeek Cement Restrictor X-Box
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasis, Inc. · JDK Prosthesis, Hip, Cement Restrictor
Cleared on Jul 22, 2004 as substantially equivalent to K031837 (Spinal Concepts, Inc., 2003) and 2 other predicates after a 41-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Jul 22, 2004
- Review
- 41 days
- Class
- Class II
- Product code
- JDK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K900138 (1990). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK900138 Motech Titanium Surgical MeshBiedermann Motech GmbH · 1990
- 3 generations backK990345 Rabea Device, Model PxxxxxxSignus Medizintechnik GmbH · 1999
- 2 generations backK021719 Fortitude Cement RestrictorSpinal Concepts, Inc. · 2002
- 1 generation backK031837 Modification to Fortitude Cement RestrictorSpinal Concepts, Inc. · 2003
- This deviceK041583 Peek Cement Restrictor X-BoxInnovasis, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K900138 | Motech Titanium Surgical Mesh | Biedermann Motech GmbH | 1990 | — |
| −3 | K990345 | Rabea Device, Model Pxxxxxx | Signus Medizintechnik GmbH | 1999 | — |
| −2 | K021719 | Fortitude Cement Restrictor | Spinal Concepts, Inc. | 2002 | — |
| −1 | K031837 | Modification to Fortitude Cement Restrictor | Spinal Concepts, Inc. | 2003 | — |
| 0 (this device) | K041583 | Peek Cement Restrictor X-Box | Innovasis, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
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
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031837 | Modification to Fortitude Cement RestrictorSummary page 1…Class II (see 21CRF, Sec. 888.3300) Device Product Code: JDK. The Panel code is 87. Substantially Spinal Concepts, Inc. (K031837, K031318, & K021719) Equivalent Devices: Medtronic Sofamor Danek (KOO 10528… | 2003 |
| * | K031318 | Traxis Cement RestrictorSummary page 1…lass II (see 21CRF, Sec. 888.3300) Device Product Code: JDK. The Panel code is 87. Substantially Spinal Concepts, Inc. (K031837, K031318, & K021719) Equivalent Devices: Medtronic Sofamor Danek (KOO 10528) Devi… | 2003 |
| * | K021719 | Fortitude Cement RestrictorSummary page 1…ct Code: JDK. The Panel code is 87. Substantially Spinal Concepts, Inc. (K031837, K031318, & K021719) Equivalent Devices: Medtronic Sofamor Danek (KOO 10528) Device Description: The INNOVASIS 'X-Box' PEEK Ceme… | 2002 |
| Kept off the family tree | K001052 | FDA’s K001052 is Med-Tec (Medical Intelligence) Bodyfix System, Model MT-BFX Our reading of the summary gave K001052, FDA’s number for Med-Tec (Medical Intelligence) Bodyfix System, Model MT-BFX (Med-Tec,Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Medtronic Sofamor Danek”. Kept off the family tree. | 2000 |
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 14 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 13 ancestors has a recall.
- 3 other devices also cite its predicate K031837.
How does its category compare?
All JDK devicesJDK Prosthesis, Hip, Cement Restrictor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDK
1in 2021
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDK
6in 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 INNOVASIS 'X-Box' PEEK Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial canal in hip stem and total knee replacement.
This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041583 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041583: Peek Cement Restrictor X-Box.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041583
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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