510(k) · Cleared
ClearedModification to: Vented Cement Restrictor, Model 60102-000-001/004
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amedica Corp. · JDK Prosthesis, Hip, Cement Restrictor
Cleared on Apr 15, 2005 as substantially equivalent to K022729 (Amedica Corp., 2002) and 1 other predicate after a 28-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Apr 15, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- JDK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K003718 (2001). 8 ancestors in all, the oldest K830949 (1983). No later device cites it as a predicate yet.
- 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 backK022729 Vented Cement RestrictorAmedica Corp. · 2002
- This deviceK050699 Modification to: Vented Cement Restrictor, Model 60102-000-001/004Amedica Corp. · 2005
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 | K022729 | Vented Cement Restrictor | Amedica Corp. | 2002 | — |
| 0 (this device) | K050699 | Modification to: Vented Cement Restrictor, Model 60102-000-001/004 | Amedica Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1990 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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? (2)
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 | Decided |
|---|---|---|---|
| * | K022729 | Vented Cement RestrictorSummary page 1…7 JDX) are Class II per 21 CFR §888.4580, reviewed by the Orthopedic Devices panel. PREDICATE DEVICES: * Amedica Vented Cement Restrictor (K022729) * Quantum Orthopedics Cement Restrictor (K040276) DEVICE DESCRIPTION: The Vented Cement Restrictor used in cemented application… | 2002 |
| * | K040276 | Quantum Cement RestrictorSummary page 1…by the Orthopedic Devices panel. PREDICATE DEVICES: * Amedica Vented Cement Restrictor (K022729) * Quantum Orthopedics Cement Restrictor (K040276) DEVICE DESCRIPTION: The Vented Cement Restrictor used in cemented applications for hip, knee, and shoulder arthroplasty, is a p… | 2004 |
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 2 companies; a new generation was cleared every 11 months on median.
- None of the 8 ancestors has a recall.
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 Vented Cement Restrictor is intended for use as a cement restrictor used in the treatment of the following:
* Total Hip Arthroplasty
* Total Knee Arthroplasty
* Total or Hemi Shoulder Arthroplasty
The device is not intended for use in spinal surgeries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050699: Modification to: Vented Cement Restrictor, Model 60102-000-001/004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050699
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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