510(k) · Cleared
ClearedOsstaple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Ent., Inc. · JDR Staple, Fixation, Bone
Cleared on Oct 17, 2002 as substantially equivalent to K993714 (Biomedical Ent., Inc., 2000) and 3 other predicates after a 22-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Oct 17, 2002
- Review
- 22 days
- Class
- Class II
- Product code
- JDR
- 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) | K023203 | Osstaple | Biomedical Ent., 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 JDR? 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 JDR device
- #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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…matic cessation by the circuitry Page 13 of 14 e. Substantial Equivalence: The Warmsystem heating unit was approved via 510(k)s K993714, 001219, 001353 and 001354 and no fundamental technology changes are reprecented with the BioWarni'h'modification.… | 2000 |
| * | K001219 | Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple SystemSummary page 2…sation by the circuitry Page 13 of 14 e. Substantial Equivalence: The Warmsystem heating unit was approved via 510(k)s K993714, 001219, 001353 and 001354 and no fundamental technology changes are reprecented with the BioWarni'h'modification.… | 2000 |
| * | K001353 | Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for…Summary page 2…y the circuitry Page 13 of 14 e. Substantial Equivalence: The Warmsystem heating unit was approved via 510(k)s K993714, 001219, 001353 and 001354 and no fundamental technology changes are reprecented with the BioWarni'h'modification. W.… | 2001 |
| * | K001354 | Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the…Summary page 2…itry Page 13 of 14 e. Substantial Equivalence: The Warmsystem heating unit was approved via 510(k)s K993714, 001219, 001353 and 001354 and no fundamental technology changes are reprecented with the BioWarni'h'modification. W. Casey Fox,… | 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 2 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 JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, 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 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
The Menogrqh@Staple is intended for:
1) hand and foot bone fragment and osteotomy fixation and joint arlhrodesis, 2) fixalion of proximal tibial metaphysic osteotomy, and 3) fixation of soft tissue to bone such as anterior cniciate reconstroction-
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023203: Osstaple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023203
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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