510(k) · Cleared
ClearedTyber Medical Staple Fixation System (various)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyber Medical, LLC · JDR Staple, Fixation, Bone
Cleared on Oct 20, 2022 as substantially equivalent to K142292 (Biomedical Enterprises, Inc., 2014) and 3 other predicates after a 107-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Oct 20, 2022
- Review
- 107 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K902307 (1990). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 4 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 3 generations backK124022 Speed ShiftBiomedical Enterprises, Inc. · 2013
- 2 generations backK133780 Speed XLBiomedical Ent., Inc. · 2014
- 1 generation backK142292 Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc. · 2014 · Recalled
- This deviceK221947 Tyber Medical Staple Fixation System (various)Tyber Medical, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −4 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −3 | K124022 | Speed Shift | Biomedical Enterprises, Inc. | 2013 | — |
| −2 | K133780 | Speed XL | Biomedical Ent., Inc. | 2014 | — |
| −1 | K142292 | Speed, Speed Shift, Speed Titan, Speed Arc | Biomedical Enterprises, Inc. | 2014 | 3 |
| 0 (this device) | K221947 | Tyber Medical Staple Fixation System (various) | Tyber Medical, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K142292 | Speed, Speed Shift, Speed Titan, Speed ArcSummary page 4…ber 888.3030 Product Code JDR | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K142292 DPS/BME Speed, Speed Shift, Speed Titanium, & Elite Nintinol fi JDR K061798/K0772298 | | BioPro Memory Staple JDR K150125 DPS/BME… | 2014 |
| * | K061798 | Biopro Memory StapleSummary page 4…807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K142292 DPS/BME Speed, Speed Shift, Speed Titanium, & Elite Nintinol fi JDR K061798/K0772298 | | BioPro Memory Staple JDR K150125 DPS/BME Elite Nitinol Fixation System JDR Device Description Summary 21 CFR 807.92(… | 2006 |
| * | K072298 | Biopro Memory Staple, Models 18062-18073 Our OCR of the scanned summary read K077298, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BioPro Memory Staple”. | 2007 |
| * | K150125 | Elite Nitinol Fixation SystemSummary page 4…(Primary Predicate is listed first) Product Code K142292 DPS/BME Speed, Speed Shift, Speed Titanium, & Elite Nintinol fi JDR K061798/K0772298 | | BioPro Memory Staple JDR K150125 DPS/BME Elite Nitinol Fixation System JDR Device Description Summary 21 CFR 807.92(a)(4) The Tyber Medical Staple Fixation Syste… | 2015 |
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 32 years and passes through 4 companies; a new generation was cleared every 7.9 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 8 other devices also cite its predicate K142292.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Tyber Medical Staple System is indicated for:
Fracture and osteotomy fixation, joint arthrodesis hand and foot.
Fixation of proximal tibial metaphysis osteotomy.
Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
Fixation of small bone fragments (i.e., small fragments of bone which are not comminuted to the
extend to preclude staple placement). These fragments may be located in long bones such as the
femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities;
the clavicle and in flat bone such as the pelvis and scapula.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221947: Tyber Medical Staple Fixation System (various).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221947
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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