510(k) Report

510(k) · Cleared

Cleared

SDB Cerclage System

K992616510(k) TraditionalCleared Oct 27, 199984-day reviewClass II21 CFR 888.3010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pioneer Surgical Technology · JDQ Cerclage, Fixation

Cleared on Oct 27, 1999 as substantially equivalent to K844068 (Howmedica Corp., 1985) and 2 other predicates after an 84-day review. Its family tree reaches back 1 generation to 1985. 10 later devices descend from it.

Decided
Oct 27, 1999
Review
84 days
Class
Class II
Product code
JDQ
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K844068 (1985). 3 ancestors in all. 10 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1990: 1 other ancestor1987: 1 other ancestor2023: 1 descendant cleared2020: 1 descendant cleared2015: 2 descendants cleared2021: 1 descendant cleared2003: 1 descendant cleared2010: 1 descendant cleared2014: 2 descendants cleared2016: 1 descendant clearedK844068 · Trochanter Cable Grip System · Howmedica Corp. · 19851990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K844068 · Trochanter Cable Grip System · Howmedica Corp. · 19850
  1. Root · 1 generation backK844068 Trochanter Cable Grip SystemHowmedica Corp. · 1985
  2. This deviceK992616 SDB Cerclage SystemPioneer Surgical Technology · 1999
  3. Descendant · cites it directly · 3 of its ownK101126 Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010
  4. Descendant · cites it directly · 1 of its ownK151888 Frontier Medical Devices In-line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc. · 2015
  5. Descendant · 2 generations on · 1 of its ownK140127 Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014
  6. Descendant · cites it directly · 0 of its ownK231333 STRETTO™ Cable SystemGlobus Medical, Inc. · 2023
  7. Descendant · cites it directly · 0 of its ownK203408 Summit Patella Plating SystemEndeavor Orthopaedics, LLC · 2021

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2003: 12010: 12014: 22015: 22016: 12020: 12021: 12023: 1
2003high 2 (2014) · low 0 (2004)2026

Most influential descendants

Showing 5 of 10 · See all
  • K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010 · cites it directly3descendants
  • K151888Frontier Medical Devices In-line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc. · 2015 · cites it directly1descendant
  • K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014 · 2 generations on1descendant
  • K231333STRETTO™ Cable SystemGlobus Medical, Inc. · 2023 · cites it directly0descendants
  • K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K844068Trochanter Cable Grip SystemHowmedica Corp.1985—
0 (this device)K992616SDB Cerclage SystemPioneer Surgical Technology1999—
+1K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc.2010—
+1K151888Frontier Medical Devices In-line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc.2015—
+2K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC2014—
+1K231333STRETTO™ Cable SystemGlobus Medical, Inc.2023—
+1K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201010
201420
201520
201610
202010
202110
202310
FIG. 1 — Lineage of K992616, 1985–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K844068Trochanter Cable Grip System
Summary page 1
…Number: CFR 888.3010 Classification Number: 871DQ Device Class: II Devices on Which Substantial Equivalence is Claimed: 1. Dall Miles “Trochanter Cable Grip System” - K844068; 2. Dall Miles “Modified Trochanter Cable Grip System” - K872224; 3. Dall Miles “Trochanter Cable Grip System (Additional Indica…
Howmedica Corp.1985—
*K872224Modified Trochanter Cable Grip System
Summary page 1
…II Devices on Which Substantial Equivalence is Claimed: 1. Dall Miles “Trochanter Cable Grip System” - K844068; 2. Dall Miles “Modified Trochanter Cable Grip System” - K872224; 3. Dall Miles “Trochanter Cable Grip System (Additional Indications)” - K900926; and 4, Stainless Steel cerclage wire, manufac…
Howmedica Corp.19872
*K900926Trochanter Cable Grip System (Add'l Indications)
Summary page 1
…r Cable Grip System” - K844068; 2. Dall Miles “Modified Trochanter Cable Grip System” - K872224; 3. Dall Miles “Trochanter Cable Grip System (Additional Indications)” - K900926; and 4, Stainless Steel cerclage wire, manufactured prior ta 1976 12 510(K) SUMMARY (Continued) Device Descrip…
Howmedica Corp.1990—
*—Stainless Steel cerclage wire, manufactured prior to 1976
Named without a submission number
—

Also cleared against K844068: 5 other devices →

What descends from it? (10)

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc.20103
K151888Frontier Medical Devices In-line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc.20151
K231333STRETTO™ Cable SystemGlobus Medical, Inc.20230
K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210
K201497EVOS Cabling SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20200
K023564Osse-LignOsseus, LLC20030

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?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K101126 (Core Essence Orthopaedics, Inc., 2010) has gone furthest, with 3 descendants of its own.
  • 5 other devices also cite its predicate K844068.

How does its category compare?

All JDQ devices

JDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDQ

2in 2025

2007: 12008: 22009: 22011: 62012: 32013: 12014: 22015: 52016: 42017: 12018: 62020: 42022: 22023: 32024: 32025: 22026 (partial year): 1
2007high 6 (2011) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDQ

130in 2024

2011: 130 days median2012: 134 days median2015: 92 days median2016: 129 days median2018: 101 days median2020: 93 days median2023: 141 days median2024: 130 days median
2007high 141 (2023) · low 92 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JDQ

5in 2019

2008: 22010: 22013: 12015: 12019: 5
2007high 5 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDQ

84in 2025

2007: 52008: 252009: 192010: 282011: 302012: 1302013: 3212014: 2232015: 2052016: 2242017: 1382018: 1822019: 1582020: 1252021: 1412022: 1342023: 982024: 1152025: 84
2007high 321 (2013) · low 5 (2007)2025

MAUDE reports naming product code JDQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—05
20082—225
20092—019
20100—228
20116130030
201231340130
20131—1321
20142—0223
20155921205
201641290224
20171—0138
201861010182
20190—5158
20204930125
20210—0141
20222—0134
20233141098
202431300115
20252—084
20261—0—

What is it indicated for?

The SDB Cerclage System devices will be offered in two sizes of cable constructs. The large cable construct shall be indicated for general orthopedic trauma surgery involving the following: olecranon, patella, femur (including periprosthetic fractures), pelvic, acetabular, humeral and ankle fractures; acromioclavicular dislocations; prophylactic banding during total joint procedures; and temporary reduction during ORIF (Open Reduction Internal Fixation) procedures. The small cable size shall be contraindicated for use in the femur ORIF and prophylactic banding during total joint procedures. These devices are intended as single use items.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K844068

5 other devices cite the same predicate.

  • K984432Dall-Miles Cable Grip (a-Grip)Howmedica Osteonics Corp. · 1999
  • K983976Metagen Activelock Wire Cerclage SystemMetagen, LLC · 1998
  • K972327Metagen Activelock Cerclage SystemPacific Materials and Interfaces · 1997
  • K971741Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp. · 1997
  • K961569Dall-Miles Stainless Steel Beaded CableHowmedica Corp. · 1996

More from Pioneer Surgical Technology

50 FDA decisions under this applicant name. See the company

  • K110561Fortross Bone Void FillerPioneer Surgical Technology · 2011
  • K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology · 2011
  • K101525Pioneer Spinous Process Fusion PlatePioneer Surgical Technology · 2010
  • K093692Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology · 2010
  • K093771Quantum/Streamline TL Mis Spinal SystemPioneer Surgical Technology · 2010

Recent decisions in JDQ

The JDQ category page

  • K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026
  • K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda. · 2025
  • K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage SuturesArthrex, Inc. · 2025
  • K232733Mbrace CableMedacta International S.A. · 2024
  • K233949ACCORD Cable SystemSmith & Nephew, Inc. · 2024

https://510kreport.com/device/K992616 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992616: SDB Cerclage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992616

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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