510(k) · Cleared
ClearedOsstaple, Craniofacial
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Enterprises, Inc. · JEY Plate, Bone
Cleared on Oct 31, 2002 as substantially equivalent to K993714 (Biomedical Ent., Inc., 2000) and 3 other predicates after a 14-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Oct 31, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K902307 (1990). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −1 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| 0 (this device) | K023488 | Osstaple, Craniofacial | Biomedical Enterprises, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 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 JEY? 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 JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993714 | Memograph Staple, Warm SystemSummary page 2…ation by the circuitry Page 13 of 14 e. Substantial Equivalence: The Warmsystem heating unit was approved via 5 1O(k)s K9937 14, 00 12 19, 00 1353 and 001 354 and no fundamental technology changes are represented with the BioWarrnlh'… | 2000 |
| * | K001219 | Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple System | 2000 |
| * | K001353 | Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for… | 2001 |
| * | K001354 | Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the… | 2001 |
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 12 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 17 other devices also cite its predicate K993714.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, 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 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
What is it indicated for?
Indications for the OSStaple'" are fixation of unloaded craniofacial bone fractures and cranioplasty. The
OSStaple"' is contraindicated for craniofacial patients with a skull thickness less than the selected prong
length.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023488 · printed Nov 3, 2026
Cite this page
510(k) Report. “K023488: Osstaple, Craniofacial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K023488
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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