510(k) · Cleared
Recalled · Class II · 2016Perfuse Percutaneous Decompression System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · FMF Syringe, Piston
Cleared on Aug 27, 2014 as substantially equivalent to K072330 (Biomet, Inc., 2007) after a 57-day review. Its family tree reaches back 3 generations to 2001. It has been recalled once.
- Decided
- Aug 27, 2014
- Review
- 57 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003286 (2001). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK003286 Symphony Graft Delivery SystemDepuyacromed · 2001
- 2 generations backK021071 PCCS Graft Delivery SystemBiomet, Inc. · 2002 · Recalled
- 1 generation backK072330 Controlled Delivery for Osteoplasty (Cdo System) and Graft…Biomet, Inc. · 2007
- This deviceK141762 Perfuse Percutaneous Decompression SystemBiomet, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003286 | Symphony Graft Delivery System | Depuyacromed | 2001 | — |
| −2 | K021071 | PCCS Graft Delivery System | Biomet, Inc. | 2002 | 1 |
| −1 | K072330 | Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System | Biomet, Inc. | 2007 | — |
| 0 (this device) | K141762 | Perfuse Percutaneous Decompression System | Biomet, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2002 | 1 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K072330 | Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemSummary page 4…h the syringe and plunger rod. Target Area: Femur, humerus with early stage necrosis Legally Marketed Devices To Which Substantial Equivalence Is Claimed: CDO™ System (K072330) consists of a curved delivery cannula, a modified syringe, a flexible plunger and an optional syringe adaptor tip. The Graft Pre… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 11, 2016 | Class II | Z-1814-2016 | Process control | The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 3 other devices also cite its predicate K072330.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The PerFuse Percutaneous Decompression System is intended to be used for the delivery of allograft, autograft, and synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate mixing and pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141762: Perfuse Percutaneous Decompression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141762
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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