510(k) · Cleared
Recalled · Class II · 2022Speed, Speed Shift, Speed Titan, Speed Arc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Enterprises, Inc. · JDR Staple, Fixation, Bone
Cleared on Nov 17, 2014 as substantially equivalent to K993714 (Biomedical Ent., Inc., 2000) and 4 other predicates after a 91-day review. Its family tree reaches back 4 generations to 1990. 13 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 17, 2014
- Review
- 91 days
- Class
- Class II
- Product code
- JDR
- Recalls
- 3
- Predicates
- 5
Its longest line of descent runs back 4 generations to K902307 (1990). 8 ancestors in all. 13 later devices descend from it, 9 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 backK124022 Speed ShiftBiomedical Enterprises, Inc. · 2013
- 1 generation backK133780 Speed XLBiomedical Ent., Inc. · 2014
- This deviceK142292 Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK193305 DynaClip Bone StapleMedShape, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK220812 DynaClip® Bone StapleMedShape, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK254110 DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip…MedShape, Inc. · 2026
- Descendant · cites it directly · 1 of its ownK203180 Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK260995 DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K193305DynaClip Bone StapleMedShape, Inc. · 2020 · cites it directly3descendants
- K220812DynaClip® Bone StapleMedShape, Inc. · 2022 · 2 generations on2descendants
- K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc. · 2026 · 2 generations on1descendant
- K203180Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2020 · cites it directly1descendant
- K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026 · 3 generations on0descendants
View 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 | K124022 | Speed Shift | Biomedical Enterprises, Inc. | 2013 | — |
| −1 | K133780 | Speed XL | Biomedical Ent., Inc. | 2014 | — |
| 0 (this device) | K142292 | Speed, Speed Shift, Speed Titan, Speed Arc | Biomedical Enterprises, Inc. | 2014 | — |
| +1 | K193305 | DynaClip Bone Staple | MedShape, Inc. | 2020 | — |
| +2 | K220812 | DynaClip® Bone Staple | MedShape, Inc. | 2022 | — |
| +2 | K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte… | MedShape, Inc. | 2026 | — |
| +1 | K203180 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | 2020 | — |
| +3 | K260995 | DynaNail Helix® Fixation System | MedShape, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (5)
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 4…flat bone such as the pelvis, scapula and sternum. Substantial Equivalence: The Speed™ is substantially equivalent to primary predicate BME OSStaple™ cleared in K993714, and reference predicates BME OSStaple™ K001354, Speed Shift™ cleared in K124022, Speed Arc™ cleared in K133270, and Speed XL™ cl… | 2000 |
| * | K001354 | Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the…Summary page 4…sternum. Substantial Equivalence: The Speed™ is substantially equivalent to primary predicate BME OSStaple™ cleared in K993714, and reference predicates BME OSStaple™ K001354, Speed Shift™ cleared in K124022, Speed Arc™ cleared in K133270, and Speed XL™ cleared in K133780.… | 2001 |
| * | K124022 | Speed ShiftSummary page 4…e: The Speed™ is substantially equivalent to primary predicate BME OSStaple™ cleared in K993714, and reference predicates BME OSStaple™ K001354, Speed Shift™ cleared in K124022, Speed Arc™ cleared in K133270, and Speed XL™ cleared in K133780.… | 2013 |
| * | K133270 | Speed ArcSummary page 4…equivalent to primary predicate BME OSStaple™ cleared in K993714, and reference predicates BME OSStaple™ K001354, Speed Shift™ cleared in K124022, Speed Arc™ cleared in K133270, and Speed XL™ cleared in K133780. K142292 (pg 2/… | 2014 |
| * | K133780 | Speed XLSummary page 4…ME OSStaple™ cleared in K993714, and reference predicates BME OSStaple™ K001354, Speed Shift™ cleared in K124022, Speed Arc™ cleared in K133270, and Speed XL™ cleared in K133780. K142292 (pg 2/3) The Speed Shift™ device is… | 2014 |
What descends from it? (13)
See all 139 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193305 | DynaClip Bone Staple | 2020 | 3 |
| K203180 | Arthrex DynaNite Nitinol Staples | 2020 | 1 |
| K232990 | A’TOMIC™ Nitinol Fixation System | 2024 | 0 |
| K231458 | Extremity Staple | 2023 | 0 |
| K221947 | Tyber Medical Staple Fixation System (various) | 2022 | 0 |
| K182943 | VERTEX Nitinol Staple System | 2019 | 0 |
| K181815 | DynaBridge | 2018 | 0 |
| K173775 | Clench Compression Staple | 2018 | 0 |
| K151615 | TiTHON Staple with OsseoTi Technology | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2022 | Class II | Z-0098-2023 | Error in labeling | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is… |
| Sep 27, 2022 | Class II | Z-0100-2023 | Error in labeling | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is… |
| Sep 27, 2022 | Class II | Z-0099-2023 | Error in labeling | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is… |
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, K193305 (MedShape, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 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. 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 Speed™, Speed Shift™, Speed Titan™ and Speed Arc™ are indicated for:
Fracture and osteotomy fixation and joint arthrodesis of the 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 extent 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 ribs; and in flat bone such as the pelvis, scapula and sternum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142292: Speed, Speed Shift, Speed Titan, Speed Arc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142292
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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