510(k) · Cleared
ClearedOrbitum Bone Staple Implant, X and VI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthovestments, LLC · JDR Staple, Fixation, Bone
Cleared on Feb 23, 2018 as substantially equivalent to K043059 (Wrightmedicaltechnologyinc, 2005) and 2 other predicates after an 84-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Feb 23, 2018
- Review
- 84 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K961522 (1996). 14 ancestors in all, the oldest K894929 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK961522 Kirschner Wire (K-Wire) and Steinmann PinSynvasive Technology, Inc. · 1996
- 3 generations backK030665 Bone WireStork Instrumente GmbH · 2003
- 2 generations backK100736 Kirschner and Guide WiresSmt Schilling Metalltechnik GmbH · 2010
- 1 generation backK121277 Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire…Z-Medical GmbH & Co. KG · 2012
- This deviceK173693 Orbitum Bone Staple Implant, X and VIOrthovestments, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961522 | Kirschner Wire (K-Wire) and Steinmann Pin | Synvasive Technology, Inc. | 1996 | — |
| −3 | K030665 | Bone Wire | Stork Instrumente GmbH | 2003 | — |
| −2 | K100736 | Kirschner and Guide Wires | Smt Schilling Metalltechnik GmbH | 2010 | — |
| −1 | K121277 | Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple | Z-Medical GmbH & Co. KG | 2012 | — |
| 0 (this device) | K173693 | Orbitum Bone Staple Implant, X and VI | Orthovestments, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 4 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 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? (3)
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 |
|---|---|---|---|
| * | K043059 | Compression Staple and Simple StapleSummary page 4…appliance and accessories (21 CFR 888.3030 Class II, Product Code JDR) C. Predicate Device: K043059 – Compression Staple and Simple Staple (Wright Medical Technologies);… | 2005 |
| * | K121277 | Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleSummary page 4…059 – Compression Staple and Simple Staple (Wright Medical Technologies); K121277 – Z –staple (Z=medical Gmbh); K161587 – Memodyn Staple (Telos Medical) D.… | 2012 |
| * | K161587 | Memodyn StapleSummary page 4…Medical Technologies); K121277 – Z –staple (Z=medical Gmbh); K161587 – Memodyn Staple (Telos Medical) D. Device Description: Orbitum Bone Staple Implants, X and VI, have either rad… | 2017 |
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 22 years and passes through 5 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 9 other devices also cite its predicate K043059.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 ORBITUM X and VI Bone Staple is indicated for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
Orbitum X and VI implants are intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis Akin osteotomy, midfoot and hindfoot arthrodesis or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173693 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173693: Orbitum Bone Staple Implant, X and VI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173693
Report an extraction error
Are you the manufacturer?
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