510(k) · Cleared
ClearedVented Cement Restrictor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amedica Corp. · JDX Instrument, Surgical, Sonic And Accessory/Attachment
Cleared on Nov 14, 2002 as substantially equivalent to K013663 (Medtronic Sofamor Danek, Inc., 2001) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Nov 14, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- JDX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K003718 (2001). 6 ancestors in all, the oldest K830949 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK003718 Titanium Cement Restrictor (TCR)Medtronic Sofamor Danek, Inc. · 2001
- 2 generations backK013014 Block Cement Restrictor (CR) - TitaniumMedtronic Sofamor Danek, Inc. · 2001
- 1 generation backK013663 Cement RestrictorMedtronic Sofamor Danek, Inc. · 2001
- This deviceK022729 Vented Cement RestrictorAmedica Corp. · 2002
- Descendant · cites it directly · 0 of its ownK050699 Modification to: Vented Cement Restrictor, Model 60102-000-001/004Amedica Corp. · 2005
Most influential descendants
Showing 1 of 1 · See all- K050699Modification to: Vented Cement Restrictor, Model 60102-000-001/004Amedica Corp. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003718 | Titanium Cement Restrictor (TCR) | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −2 | K013014 | Block Cement Restrictor (CR) - Titanium | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −1 | K013663 | Cement Restrictor | Medtronic Sofamor Danek, Inc. | 2001 | — |
| 0 (this device) | K022729 | Vented Cement Restrictor | Amedica Corp. | 2002 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 JDX? 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 JDX device
- #1 K201274 Ultrasonic Osteotomy Surgical Systemscore 3.3 · 9 generations · no Class I recall
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K013663 | Cement Restrictor | 2001 |
| Kept off the family tree | K511060 | Polyethylene Medullary Plug Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | K900462 | Osteonics Cement RestrictorSummary page 1…tive devices: . Medtronic Sofamor Danek Cement Restrictor, KO 13663 Polyethylene Medullary Plug, KS 11060 Osteonics Cement Restrictor, K900462 . Polyethylene Medullary Plug, K830949 Seidel lntramedullary Plug, K72205 DEPARTMENT O… | 1990 |
| * | K830949 | Polyethylene Medullary Plug - Stiihmer/Summary page 1…Cement Restrictor, KO 13663 Polyethylene Medullary Plug, KS 11060 Osteonics Cement Restrictor, K900462 . Polyethylene Medullary Plug, K830949 Seidel lntramedullary Plug, K72205 DEPARTMENT OF HEALTH & HUMAN SERVICES… | 1983 |
| Kept off the family tree | K072205 | FDA’s K072205 is Visage Pacs/CS, Release Version 5.0 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050699 | Modification to: Vented Cement Restrictor, Model 60102-000-001/004 | 2005 | 0 |
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 1 year and passes through 2 companies; a new generation was cleared every 8 months on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K050699 (Amedica Corp., 2005) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K013663.
How does its category compare?
All JDX devicesJDX Instrument, Surgical, Sonic And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDX
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JDX
Too few JDX 510(k)s in any year since 2007 to give a median.
Recalls per year · JDX
No recall names JDX since 2007.
Adverse event reports per year · JDX
9in 2025
MAUDE reports naming product code JDX, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 16 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 8 |
| 2018 | 1 | — | 0 | 42 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 9 |
| 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/K022729 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022729: Vented Cement Restrictor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022729
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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