510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial Locking Plate

K120772510(k) TraditionalCleared Jun 12, 201290-day reviewClass II21 CFR 888.3030Recalls 2

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

Zimmer GmbH · HRS Plate, Fixation, Bone

Cleared on Jun 12, 2012 as substantially equivalent to K100111 (Zimmer, Inc., 2010) and 2 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1998. 6 later devices descend from it. It has been recalled 2 times.

Decided
Jun 12, 2012
Review
90 days
Class
Class II
Product code
HRS
Recalls
2
Predicates
3

Its longest line of descent runs back 5 generations to K981372 (1998). 23 ancestors in all, the oldest K953777 (1996). 6 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2000: 6 other ancestors2004: 2 other ancestors1999: 3 other ancestors2001: 2 other ancestors1997: 1 other ancestor1996: 2 other ancestors1998: 1 other ancestor2021: 2 descendants cleared2017: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant clearedK981372 · Synthes 3.0 MM PC-Fix System · Synthes (Usa) · 1998K991407 · Synthes Locking Calcaneal Plates · Synthes (Usa) · 1999K033669 · Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) · Smith & Nephew, Inc. · 2003 · recalledK082807 · Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications · Synthes (Usa) · 2008K100111 · NCB Periprosthetic Femur Polyaxial Locking Plate System · Zimmer, Inc. · 2010 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 9 other ancestors4 generations back: 2 other ancestors5 generations back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 1 descendant K100111 · NCB Periprosthetic Femur Polyaxial Locking Plate System · Zimmer, Inc. · 2010 · recalledK082807 · Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications · Synthes (Usa) · 2008K033669 · Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) · Smith & Nephew, Inc. · 2003 · recalledK991407 · Synthes Locking Calcaneal Plates · Synthes (Usa) · 1999K981372 · Synthes 3.0 MM PC-Fix System · Synthes (Usa) · 1998−50
  1. Root · 5 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
  2. 4 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
  3. 3 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
  4. 2 generations backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
  5. 1 generation backK100111 NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc. · 2010 · Recalled
  6. This deviceK120772 NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button…Zimmer GmbH · 2012
  7. Descendant · cites it directly · 1 of its ownK210247 OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021
  8. Descendant · cites it directly · 0 of its ownK261038 Xpert PFPNewclip Technics · 2026
  9. Descendant · cites it directly · 0 of its ownK241754 NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate…Zimmer Switzerland Manufacturing GmbH · 2024
  10. Descendant · 2 generations on · 0 of its ownK230764 OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies · 2023
  11. Descendant · cites it directly · 0 of its ownK201728 Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria e Comercio Ltda. · 2021

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2017: 12021: 22023: 12024: 12026: 1
2017high 2 (2021) · low 0 (2018)2026

Most influential descendants

Showing 5 of 6 · See all
  • K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021 · cites it directly1descendant
  • K261038Xpert PFPNewclip Technics · 2026 · cites it directly0descendants
  • K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable…Zimmer Switzerland Manufacturing GmbH · 2024 · cites it directly0descendants
  • K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies · 2023 · 2 generations on0descendants
  • K201728Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria e Comercio Ltda. · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K981372Synthes 3.0 MM PC-Fix SystemSynthes (Usa)1998—
−4K991407Synthes Locking Calcaneal PlatesSynthes (Usa)1999—
−3K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc.20031
−2K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded…Synthes (Usa)2008—
−1K100111NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc.20102
0 (this device)K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB…Zimmer GmbH2012—
+1K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma2021—
+1K261038Xpert PFPNewclip Technics2026—
+1K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System…Zimmer Switzerland Manufacturing GmbH2024—
+2K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies2023—
+1K201728Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria e Comercio Ltda.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199710
199810
199930
200060
200120
200420
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202120
202310
202410
202610
FIG. 1 — Lineage of K120772, 1998–2026Source: 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 HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K100111NCB Periprosthetic Femur Polyaxial Locking Plate System
Summary page 1
…Washer, Bolt, Nut (21 CER 888.3030) Predicate Devices: 1) NCB Periprosthetic Femur Polyaxial Locking Plate System, Manufactured by Zimmer, K1 001 111, cleared April 12, 2010, and Pioneer Surgical Technology Extended GTR, Model…
Zimmer, Inc.20102
*K000734Pioneer Surgical Technology Extended GTR, Model 501-601
Summary page 1
…l 12, 2010, and Pioneer Surgical Technology Extended GTR, Model 501-601, Manufactured by Pioneer Surgical Technology, K000734, cleared May 5, 2000. 2) Cable Ready®Q Cable Grip System Cable Button,…
Pioneer Surgical Technology2000—
*K091799Cable Ready Cable Grip System Cable Button
Summary page 1
…cleared May 5, 2000. 2) Cable Ready®Q Cable Grip System Cable Button, Manufactured by Zimmer, K09 1799, cleared September 11, 2009…
Zimmer, Inc.2009—

Also cleared against K100111: 4 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211
K261038Xpert PFPNewclip Technics20260
K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable…Zimmer Switzerland Manufacturing GmbH20240
K201728Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria e Comercio Ltda.20210
K163003Y3 Proximal Femoral Plate SystemPega Medical, Inc.20170

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 10, 2019Class IIZ-0330-2020Packaging change controlNon-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Oct 10, 2019Class IIZ-0338-2020Packaging change controlNon-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
  • 5 of the 23 ancestors have a recall of any class.
  • Of its descendants, K210247 (Osteocentric Technologies D.B.A. Osteocentric Trauma, 2021) has gone furthest, with 1 descendant of its own.
  • 4 other devices also cite its predicate K100111.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The NCB Periprosthetic Trochanter Plate when used in combination with the NCB Periprosthetic Proximal Femur Plate, short (Length =115mm) is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the greater trochanter. The NCB Periprosthetic Troehanter Plate when used in combination with the NCR Periprosthetic Proximal Femur Plates (Length =245mm, 285mm, 324mm, 363mm, 401 mm) is indicated for temporary internal…

Read the full statement (146 words)

The NCB Periprosthetic Trochanter Plate when used in combination with the NCB Periprosthetic Proximal Femur Plate, short (Length =115mm) is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the greater trochanter.

The NCB Periprosthetic Troehanter Plate when used in combination with the NCR Periprosthetic Proximal Femur Plates (Length =245mm, 285mm, 324mm, 363mm, 401 mm) is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the proximal femur.

In addition, both combinations are indicated for:

" Re-attachment of the greater trochanter following osteotomy in THA

* Re-attachment of the greater trochanter following fracture of greater trochanter

* Periprosthetic fractures

* Comminuted fractures

* Fractures in osteopenic bone

" Nonunions

* Malunions

The Cable Button is intended for use in combination with the Zimmer Locking Bone Plating Systems and Cerclage Cables, to stabilize multiple fractures or butterfly fragments in long bones.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K120772: NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial Locking Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120772

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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