510(k) · Cleared
ClearedCompressyn Staple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dallen Medical, Inc. · JDR Staple, Fixation, Bone
Cleared on Jun 2, 2014 as substantially equivalent to K122871 (Dallen Medical, Inc., 2013) and 1 other predicate after a 110-day review. Its family tree reaches back 4 generations to 1990. 2 later devices descend from it.
- Decided
- Jun 2, 2014
- Review
- 110 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K902307 (1990). 8 ancestors in all, the oldest K840566 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 3 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 2 generations backK122871 Compressyn StapleDallen Medical, Inc. · 2013
- 1 generation backK132875 Compressyn StapleDallen Medical, Inc. · 2013
- This deviceK140358 Compressyn StapleDallen Medical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK172205 ExoToe StapleExotoe, LLC · 2018
- Descendant · cites it directly · 0 of its ownK171473 Compressyn™ StapleDallen Medical, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −3 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −2 | K122871 | Compressyn Staple | Dallen Medical, Inc. | 2013 | — |
| −1 | K132875 | Compressyn Staple | Dallen Medical, Inc. | 2013 | — |
| 0 (this device) | K140358 | Compressyn Staple | Dallen Medical, Inc. | 2014 | — |
| +1 | K172205 | ExoToe Staple | Exotoe, LLC | 2018 | — |
| +1 | K171473 | Compressyn™ Staple | Dallen Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 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 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? (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 |
|---|---|---|---|
| * | K122871 | Compressyn StapleSummary page 1…and accessories, CFR 888.3030 (code JDR) DEVICE CLASSIFICATION: Class 11 PREDICATE DEVICES: Dallen Medical, Inc. Compressyn- Staple (K122871) Dallen Medical, Inc. Compressynm Staple (K132875) Product Description: The Compressynm St… | 2013 |
| * | K132875 | Compressyn StapleSummary page 1…Class 11 PREDICATE DEVICES: Dallen Medical, Inc. Compressyn- Staple (K122871) Dallen Medical, Inc. Compressynm Staple (K132875) Product Description: The Compressynm Staple is a fully integrated system that consists of a stainless steel staple preloaded… | 2013 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K172205 (Exotoe, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K122871.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 Compressyn" Staple is intended for: I) hand and foot bane fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial nietaphysis osteotomy, 3) adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremity; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in the flat bones such as the pelvis, scapula and sternum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140358: Compressyn Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140358
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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