510(k) · Cleared
ClearedSTRETTO™ Cable System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · JDQ Cerclage, Fixation
Cleared on Aug 4, 2023 as substantially equivalent to K992616 (Pioneer Surgical Technology, 1999) and 2 other predicates after an 88-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Aug 4, 2023
- Review
- 88 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K962616 (1996). 50 ancestors in all, the oldest K844068 (1985). No later device cites it as a predicate yet.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
- 2 generations backK120689 Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012
- 1 generation backK162124 Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension…DePuy Synthes · 2017
- This deviceK231333 STRETTO™ Cable SystemGlobus Medical, Inc. · 2023
Show all 10 generations
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 3 generations backK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
- 2 generations backK120689 Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012
- 1 generation backK162124 Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension…DePuy Synthes · 2017
- This deviceK231333 STRETTO™ Cable SystemGlobus Medical, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −9 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −8 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −7 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −4 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −3 | K083286 | Orthopediatrics Pediloc Locking Plate System | OrthoPediatrics Corp. | 2009 | 5 |
| −2 | K120689 | Synthes 3.5 MM VA-LCP Proximal Tibia Plate System | Synthes (USA) Products, LLC | 2012 | — |
| −1 | K162124 | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable… | DePuy Synthes | 2017 | — |
| 0 (this device) | K231333 | STRETTO™ Cable System | Globus Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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 JDQ? 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 JDQ device
- #1 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 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 |
|---|---|---|---|
| * | K992616 | SDB Cerclage SystemSummary page 4…astener Product Code: JDQ (primary), HWC, HRS Regulatory Class: II Primary Predicate: Pioneer Laboratories SDB Cerclage System (K992616) Additional Predicates: Pioneer Laboratories Hex Button Device (K992617) Synthes Variable Angle Posi… | 1999 |
| * | K992617 | Hex ButtonSummary page 4…Regulatory Class: II Primary Predicate: Pioneer Laboratories SDB Cerclage System (K992616) Additional Predicates: Pioneer Laboratories Hex Button Device (K992617) Synthes Variable Angle Positioning Pins (K162124) Purpose: The purpose of this submission is to request cle… | 1999 |
| * | K162124 | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…Summary page 4…B Cerclage System (K992616) Additional Predicates: Pioneer Laboratories Hex Button Device (K992617) Synthes Variable Angle Positioning Pins (K162124) Purpose: The purpose of this submission is to request clearance for the STRETTO™ Cable System. Device Description: The STRETTO… | 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 27 years and passes through 8 companies; a new generation was cleared every 3.3 years on median.
- 12 of the 50 ancestors have a recall of any class.
- 5 other devices also cite its predicate K992616.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · JDQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDQ
130in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDQ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDQ
84in 2025
MAUDE reports naming product code JDQ, 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 | 1 | — | 0 | 5 |
| 2008 | 2 | — | 2 | 25 |
| 2009 | 2 | — | 0 | 19 |
| 2010 | 0 | — | 2 | 28 |
| 2011 | 6 | 130 | 0 | 30 |
| 2012 | 3 | 134 | 0 | 130 |
| 2013 | 1 | — | 1 | 321 |
| 2014 | 2 | — | 0 | 223 |
| 2015 | 5 | 92 | 1 | 205 |
| 2016 | 4 | 129 | 0 | 224 |
| 2017 | 1 | — | 0 | 138 |
| 2018 | 6 | 101 | 0 | 182 |
| 2019 | 0 | — | 5 | 158 |
| 2020 | 4 | 93 | 0 | 125 |
| 2021 | 0 | — | 0 | 141 |
| 2022 | 2 | — | 0 | 134 |
| 2023 | 3 | 141 | 0 | 98 |
| 2024 | 3 | 130 | 0 | 115 |
| 2025 | 2 | — | 0 | 84 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The STRETTOTM Cable System is indicated for use in: general orthopedic trauma surgery (e.g., fractures of the olecranon, patella, femur - including periprosthetic, pelvis, acetabulum, humerus and ankle, and acromioclavicular dislocations); prophylactic banding during total joint procedures; and, temporary reduction techniques for ORIF (Open Reduction Internal Fixation) procedures. STRETTOTM Screw Anchors are indicated for fractures that may not be…
Read the full statement (124 words)
The STRETTOTM Cable System is indicated for use in: general orthopedic trauma surgery (e.g., fractures of the olecranon, patella, femur - including periprosthetic, pelvis, acetabulum, humerus and ankle, and acromioclavicular dislocations); prophylactic banding during total joint procedures; and, temporary reduction techniques for ORIF (Open Reduction Internal Fixation) procedures.
STRETTOTM Screw Anchors are indicated for fractures that may not be securely held by either a screw or a cerclage device alone, and where cerclage is used in combination with bone screws and/or plates to provide internal fixation of fractured bone.
STRETTOTM Press-In Anchors are indicated for use with a cerclage cable and plate to augment long bone fracture fixation, particularly when the use of screws would be inhibited, as in the presence of intramedullary implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231333 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231333: STRETTO™ Cable System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231333
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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