510(k) Report

510(k) · Cleared

Recalled · 2010

Supercable Grip and Plate System

K072250510(k) TraditionalCleared Nov 9, 200788-day reviewClass II21 CFR 888.3030Recalls 1

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

Kinamed, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Nov 9, 2007 as substantially equivalent to K961267 (Pioneer Surgical Technology, 1996) and 6 other predicates after an 88-day review. Its family tree reaches back 4 generations to 1985. 1 later device descends from it. It has been recalled once.

Decided
Nov 9, 2007
Review
88 days
Class
Class II
Product code
KTT
Recalls
1
Predicates
7

Its longest line of descent runs back 4 generations to K844068 (1985). 21 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2003: 1 other ancestor2000: 2 other ancestors1997: 3 other ancestors1996: 1 other ancestor1998: 1 other ancestor1994: 3 other ancestors1992: 1 other ancestor1995: 2 other ancestors1990: 1 other ancestor1988: 1 other ancestor2026: 1 descendant clearedK844068 · Trochanter Cable Grip System · Howmedica Corp. · 1985K961569 · Dall-Miles Stainless Steel Beaded Cable · Howmedica Corp. · 1996K971741 · Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable · Howmedica Corp. · 1997K982545 · BMP Cable System · Biomet, Inc. · 1998 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 5 other ancestors3 generations back: 4 other ancestors4 generations back: 2 other ancestors 1 generation forward: 1 descendant K982545 · BMP Cable System · Biomet, Inc. · 1998 · recalledK971741 · Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable · Howmedica Corp. · 1997K961569 · Dall-Miles Stainless Steel Beaded Cable · Howmedica Corp. · 1996K844068 · Trochanter Cable Grip System · Howmedica Corp. · 19850
  1. Root · 4 generations backK844068 Trochanter Cable Grip SystemHowmedica Corp. · 1985
  2. 3 generations backK961569 Dall-Miles Stainless Steel Beaded CableHowmedica Corp. · 1996
  3. 2 generations backK971741 Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp. · 1997
  4. 1 generation backK982545 BMP Cable SystemBiomet, Inc. · 1998 · Recalled
  5. This deviceK072250 Supercable Grip and Plate SystemKinamed, Inc. · 2007
  6. Descendant · cites it directly · 0 of its ownK261038 Xpert PFPNewclip Technics · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K261038Xpert PFPNewclip Technics · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K844068Trochanter Cable Grip SystemHowmedica Corp.1985—
−3K961569Dall-Miles Stainless Steel Beaded CableHowmedica Corp.1996—
−2K971741Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp.1997—
−1K982545BMP Cable SystemBiomet, Inc.19981
0 (this device)K072250Supercable Grip and Plate SystemKinamed, Inc.2007—
+1K261038Xpert PFPNewclip Technics2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199010
199210
199430
199520
199610
199730
199810
200020
200310
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K072250, 1985–2026Source: 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 KTT? 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 KTT device

  1. #1 K242861 TrueLok Elevatescore 21.3 · 14 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? (7)

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
*K961267Pioneer System GTR (Greater Trochanteer Reattachment) Device
Summary page 1
…Date prepared: August 10, 2007 Trade name: SuperCable TM Grip and Plate System Substantial equivalence claimed to (see Section 9.7): a) K961267- Pioneer, Greater Trochanter Reattachment Device b) K972223 - Pioneer, Bone Plate with Cables c) K982545 - Biomet,…
Pioneer Surgical Technology1996—
*K972223Bone Plate with Cables
Summary page 1
…SuperCable TM Grip and Plate System Substantial equivalence claimed to (see Section 9.7): a) K961267- Pioneer, Greater Trochanter Reattachment Device b) K972223 - Pioneer, Bone Plate with Cables c) K982545 - Biomet, BMP Cable System d) K000734 - Pioneer, Extended Greater Troc…
Pioneer Surgical Technology1997—
*K982545BMP Cable System
Summary page 1
…uivalence claimed to (see Section 9.7): a) K961267- Pioneer, Greater Trochanter Reattachment Device b) K972223 - Pioneer, Bone Plate with Cables c) K982545 - Biomet, BMP Cable System d) K000734 - Pioneer, Extended Greater Trochanter Reattachment Device e) K00 1709 - Pion…
Biomet, Inc.19981
*K000734Pioneer Surgical Technology Extended GTR, Model 501-601
Summary page 1
…a) K961267- Pioneer, Greater Trochanter Reattachment Device b) K972223 - Pioneer, Bone Plate with Cables c) K982545 - Biomet, BMP Cable System d) K000734 - Pioneer, Extended Greater Trochanter Reattachment Device e) K00 1709 - Pioneer, Trochanteric Reattachment Device f)…
Pioneer Surgical Technology2000—
*K001709Trochanteric Reattachment Device (Standard) and (Long), Model 501-066, 501-067
Summary page 1
…223 - Pioneer, Bone Plate with Cables c) K982545 - Biomet, BMP Cable System d) K000734 - Pioneer, Extended Greater Trochanter Reattachment Device e) K00 1709 - Pioneer, Trochanteric Reattachment Device f) K032559 - Synthes, Titanium Locking Screws g) K051986 - Synthes, LCP…
Pioneer Surgical Technology2000—
*K032559Synthes 4.0MM Titanium (TI.) Locking Screws
Summary page 1
…t, BMP Cable System d) K000734 - Pioneer, Extended Greater Trochanter Reattachment Device e) K00 1709 - Pioneer, Trochanteric Reattachment Device f) K032559 - Synthes, Titanium Locking Screws g) K051986 - Synthes, LCP Straight Reconstruction Plates Device Description: The Supe…
Synthes (Usa)2003—
*K051986Synthes 4.5 MM LCP Straight Reconstruction Plates
Summary page 1
…nded Greater Trochanter Reattachment Device e) K00 1709 - Pioneer, Trochanteric Reattachment Device f) K032559 - Synthes, Titanium Locking Screws g) K051986 - Synthes, LCP Straight Reconstruction Plates Device Description: The SuperCableT M Grip and Plate System consists of trochante…
Synthes (Usa)2005—

Also cleared against K961267: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K261038Xpert PFPNewclip Technics20260

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 18, 2010Not classifiedZ-2588-2011Nonconforming Material/ComponentThe recall was initiated due to inadequate mechanical strength of these screwdrivers' hexagonal tip feature, causing it to strip during final tightening.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
  • 2 of the 21 ancestors have a recall of any class.
  • Of its descendants, K261038 (Newclip Technics, 2026) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K961267.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

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

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

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

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

What is it indicated for?

The SuperCable Grip and Plate System is indicated for use where wire, cable, or band cerclage is used in combination with a trochanteric grip or bone plate. The SuperCable Grip and Plate System is intended to be used in conjunction with the SuperCable TM Iso-Elastic Cerclage System for reattachment of the greater trochanter following osteotomy or fracture, and for fixation of long bone fractures.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K072250: Supercable Grip and Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072250

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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