510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

Trauma Internal Fixation Systems

K111663510(k) TraditionalCleared Mar 12, 2012272-day reviewClass II21 CFR 888.3030Recalls 17

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

DePuy Orthopaedics, Inc. · HRS Plate, Fixation, Bone

Cleared on Mar 12, 2012 as substantially equivalent to K103408 (DePuy Orthopaedics, Inc., 2010) and 52 other predicates after a 272-day review. Its family tree reaches back 7 generations to 1996. 1 later device descends from it. It has been recalled 17 times.

Decided
Mar 12, 2012
Review
272 days
Class
Class II
Product code
HRS
Recalls
17
Predicates
53

Its longest line of descent runs back 7 generations to K962616 (1996). 96 ancestors in all, the oldest K791619 (1979). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2010: 4 other ancestors2009: 6 other ancestors2008: 2 other ancestors2007: 3 other ancestors2006: 4 other ancestors2004: 7 other ancestors2003: 2 other ancestors2002: 2 other ancestors2000: 6 other ancestors1999: 4 other ancestors1998: 7 other ancestors1997: 6 other ancestors1996: 2 other ancestors1995: 3 other ancestors1993: 2 other ancestors1992: 3 other ancestors1991: 4 other ancestors1990: 3 other ancestors1989: 2 other ancestors1987: 3 other ancestors1982: 1 other ancestor2005: 1 other ancestor2001: 7 other ancestors1994: 1 other ancestor1988: 1 other ancestor1986: 1 other ancestor1979: 1 other ancestor2025: 1 descendant clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 3 generations cleared close together, K023007 (2002), K030198 (2003), K032705 (2003) K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK060864 · Multidirectional Threaded Peg · Hand Innovations, LLC · 200619801990200020102020
  1. Root · 7 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 6 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 5 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 4 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 3 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 2 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 1 generation backK060864 Multidirectional Threaded PegHand Innovations, LLC · 2006
  8. This deviceK111663 Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012
  9. Descendant · cites it directly · 0 of its ownK243761 A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−6K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−5K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−4K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−3K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−2K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−1K060864Multidirectional Threaded PegHand Innovations, LLC2006—
0 (this device)K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012—
+1K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198210
198610
198730
198810
198920
199030
199140
199230
199320
199410
199530
199620
199760
199870
199940
200060
200170
200220
200320
200470
200510
200640
200730
200820
200960
201040
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K111663, 1996–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (53)

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
*K103408Posterior Lateral Plates
Summary page 1
…modifications have been made to the devices and they are identical to their predicates. K103408, K101421, K082300 Anatomic Locked Plating System K093474, K091294 Fracture, [CL and Fusion Plating Sy…
DePuy Orthopaedics, Inc.2010—
*K101421Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model…
Summary page 1
…modifications have been made to the devices and they are identical to their predicates. K103408, K101421, K082300 Anatomic Locked Plating System K093474, K091294 Fracture, [CL and Fusion Plating Systems…
DePuy Orthopaedics, Inc.2010—
*K082300Anatomic Locking Plating System
Summary page 1
…modifications have been made to the devices and they are identical to their predicates. K103408, K101421, K082300 Anatomic Locked Plating System K093474, K091294 Fracture, [CL and Fusion Plating Systems…
DePuy Orthopaedics, Inc.20092
*K093474Depuy Fracture and Fusion Plating System
Summary page 1
…ntical to their predicates. K103408, K101421, K082300 Anatomic Locked Plating System K093474, K091294 Fracture, [CL and Fusion Plating Systems K101240 ALPS Small Bone Locked Plating System…
DePuy Orthopaedics, Inc.20102
*K091294Lateral Column Length Plate, Model 824073000-3, Locked Fusion Plate, Model 824077010…
Summary page 1
…their predicates. K103408, K101421, K082300 Anatomic Locked Plating System K093474, K091294 Fracture, [CL and Fusion Plating Systems K101240 ALPS Small Bone Locked Plating System…
DePuy Orthopaedics, Inc.2009—
*K101240Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22…
Summary page 1
…103408, K101421, K082300 Anatomic Locked Plating System K093474, K091294 Fracture, [CL and Fusion Plating Systems K101240 ALPS Small Bone Locked Plating System K090877 Proximal Tibia Locking Plating System…
DePuy Orthopaedics, Inc.2010—
*K090877Proximal Tibia Locking Plate Standard and Large, 3.5MM Low Profile and Multidirectional…
Summary page 1
…K093474, K091294 Fracture, [CL and Fusion Plating Systems K101240 ALPS Small Bone Locked Plating System K090877 Proximal Tibia Locking Plating System K090492, K083364, K081546 Small Bone Locking Plating System…
DePuy Orthopaedics, Inc.2009—
*K0904921.5MM Small Locking Plate, 1.5MM Non-Locking and Locking Screws
Summary page 1
…K101240 ALPS Small Bone Locked Plating System K090877 Proximal Tibia Locking Plating System K090492, K083364, K081546 Small Bone Locking Plating System K090374 Sterile DVR K…
DePuy Orthopaedics, Inc.2009—
*K0833642.5 MM Multidirectional Threaded Pegs, Models 131211110-131211130, 1.5 MM Locking…
Summary page 1
…K101240 ALPS Small Bone Locked Plating System K090877 Proximal Tibia Locking Plating System K090492, K083364, K081546 Small Bone Locking Plating System K090374 Sterile DVR K083843 Lo…
DePuy Orthopaedics, Inc.2008—
*K081546Small Bone Locking Plating System
Summary page 1
…K101240 ALPS Small Bone Locked Plating System K090877 Proximal Tibia Locking Plating System K090492, K083364, K081546 Small Bone Locking Plating System K090374 Sterile DVR K083843 Locking Ana…
DePuy Orthopaedics, Inc.20081
*K090374Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM…
Summary page 1
…K090877 Proximal Tibia Locking Plating System K090492, K083364, K081546 Small Bone Locking Plating System K090374 Sterile DVR K083843 Locking Anatomic and Composite Plating System K072832…
DePuy Orthopaedics, Inc.2009—
*K083843Locking Anatomic & Composite Plating System
Summary page 1
…ystem K090492, K083364, K081546 Small Bone Locking Plating System K090374 Sterile DVR K083843 Locking Anatomic and Composite Plating System K072832 Anterolateral and Medial Locking Plating System…
DePuy Orthopaedics, Inc.20092
*K072832Anterolateral and Medial Locking Plating System
Summary page 1
…ting System K090374 Sterile DVR K083843 Locking Anatomic and Composite Plating System K072832 Anterolateral and Medial Locking Plating System K072423 4.5mm Locking Broad & Narrow Compression Plat…
DePuy Orthopaedics, Inc.20072
*K0724234.5MM Locking Broad & Narrow Compression Plates, 4.5MM & 5.5MM Cortical & Cancellous…
Summary page 1
…K083843 Locking Anatomic and Composite Plating System K072832 Anterolateral and Medial Locking Plating System K072423 4.5mm Locking Broad & Narrow Compression Plates K072083 Small Fragment Locking Plating System…
DePuy Orthopaedics, Inc.2007—
*K072083Small Fragment Locking Plating System
Summary page 1
…K072832 Anterolateral and Medial Locking Plating System K072423 4.5mm Locking Broad & Narrow Compression Plates K072083 Small Fragment Locking Plating System K061748 Fragment Plate System K0609…
DePuy Orthopaedics, Inc.20072
*K061748Fragment Plate System
Summary page 1
…K072423 4.5mm Locking Broad & Narrow Compression Plates K072083 Small Fragment Locking Plating System K061748 Fragment Plate System K060969 Polyax Locked Plating System K050932 Distal…
Hand Innovations, LLC2006—
*K060969Polyax Locked Plating System
Summary page 1
…on Plates K072083 Small Fragment Locking Plating System K061748 Fragment Plate System K060969 Polyax Locked Plating System K050932 Distal Volar Radius Anatomical Plate System Sterilization Param…
DePuy Orthopaedics, Inc.200610
*K050932Distal Volar Radius Anatomical Plate System
Summary page 1
…ing Plating System K061748 Fragment Plate System K060969 Polyax Locked Plating System K050932 Distal Volar Radius Anatomical Plate System Sterilization Parameters for the DePuy Internal Fixation Systems…
Hand Innovations, Inc.20051
*K003235PE.R.I. II Knee Fracture System
Summary page 2
…9 Traditional 510(k) K111663 aoeIF K003235 PERt 11Knee Fracture System K993465, K981775 Calcaneal Peri-Articular Plate…
DePuy Orthopaedics, Inc.2000—
*K993465Depuy Ace Calcaneal Peri-Articular Plate
Summary page 2
…aoeIF K003235 PERt 11Knee Fracture System K993465, K981775 Calcaneal Peri-Articular Plate K990392 DePuy ACE Spider Plate K9…
Depuy, Inc.2000—
*K981775Depuy Ace Timax Calcaneal Peri-Articular Plate
Summary page 2
…aoeIF K003235 PERt 11Knee Fracture System K993465, K981775 Calcaneal Peri-Articular Plate K990392 DePuy ACE Spider Plate K990120 DeP…
Depuy Ace Medical Co.1998—
*K990392Depuy Ace Spider Plate
Summary page 2
…= K003235 PERt 11Knee Fracture System K993465, K981775 Calcaneal Peri-Articular Plate K990392 DePuy ACE Spider Plate K990120 DePuy ACE TiMax Medial Pilon Plate K9838S3…
Depuy Ace Medical Co.1999—
*K990120Modification of Depuy Ace Timax Medial Pilon Plate
Summary page 2
…System K993465, K981775 Calcaneal Peri-Articular Plate K990392 DePuy ACE Spider Plate K990120 DePuy ACE TiMax Medial Pilon Plate K9838S3 DePuy ACE TiMAX Meta Plate K97…
Depuy Ace Medical Co.1999—
*K983853Depuy Ace Timax Meta PlateDepuy Ace Medical Co.1998—
*K972629Depuy AE TK2 Hip Screw System
Summary page 2
…r Plate K990120 DePuy ACE TiMax Medial Pilon Plate K9838S3 DePuy ACE TiMAX Meta Plate K972629 DePuy ACE TK2 Hip Screw System K970503, K950618, K813554 DePuy Ace Trochanteric Side Plate, Supracond…
Depuy, Inc.19972
*K970503Depuy Ace Trochanteric Side Plate
Summary page 2
…Pilon Plate K9838S3 DePuy ACE TiMAX Meta Plate K972629 DePuy ACE TK2 Hip Screw System K970503, K950618, K813554 DePuy Ace Trochanteric Side Plate, Supracondylar Plate, Captured Hip Screw…
Depuy Ace Medical Co.1997—
*K950618Ace Supracondylar Plate
Summary page 2
…te K9838S3 DePuy ACE TiMAX Meta Plate K972629 DePuy ACE TK2 Hip Screw System K970503, K950618, K813554 DePuy Ace Trochanteric Side Plate, Supracondylar Plate, Captured Hip Screw…
Ace Medical Co.1995—
*K813554Ace/Kyle Captured Hip Screw
Summary page 2
…K9838S3 DePuy ACE TiMAX Meta Plate K972629 DePuy ACE TK2 Hip Screw System K970503, K950618, K813554 DePuy Ace Trochanteric Side Plate, Supracondylar Plate, Captured Hip Screw…
Ace Orthopedic Manufacturing Co.1982—
*K930592Ace Universal Reconstruction Plate
Summary page 2
…K970503, K950618, K813554 DePuy Ace Trochanteric Side Plate, Supracondylar Plate, Captured Hip Screw K930592 Universal Reconstruction Plate K920738 ACE 100 Degree Tubular Plate K9057…
Ace Medical Co.1993—
*K920738Ace 100 Degrees Tubular Plate
Summary page 2
…Plate, Supracondylar Plate, Captured Hip Screw K930592 Universal Reconstruction Plate K920738 ACE 100 Degree Tubular Plate K905774 Titanium Mini-Plating System K905595…
Ace Orthopedic Manufacturing Co.1992—
*K905774Thackray Titanium Mini-Plating System
Summary page 2
…Hip Screw K930592 Universal Reconstruction Plate K920738 ACE 100 Degree Tubular Plate K905774 Titanium Mini-Plating System K905595 ACE Reconstruction Plate K060864 Mul…
Depuy, Inc.1991—
*K905595Ace Reconstructive Plate
Summary page 2
…ction Plate K920738 ACE 100 Degree Tubular Plate K905774 Titanium Mini-Plating System K905595 ACE Reconstruction Plate K060864 Multidirectional Threaded Peg K954485 6.…
Ace Medical Co.1991—
*K060864Multidirectional Threaded Peg
Summary page 2
…e Tubular Plate K905774 Titanium Mini-Plating System K905595 ACE Reconstruction Plate K060864 Multidirectional Threaded Peg K954485 6.5mm solid cancellous bone screw K…
Hand Innovations, LLC2006—
*K9544856.5MM Solid Cancellous Bone Screw
Summary page 2
…Plating System K905595 ACE Reconstruction Plate K060864 Multidirectional Threaded Peg K954485 6.5mm solid cancellous bone screw K926047 8.0mm cannulated cancellous bone screw…
Ace Medical Co.1995—
*K926047Ace 8.0MM Cannulated Cancellous Bone Screw
Summary page 2
…Plate K060864 Multidirectional Threaded Peg K954485 6.5mm solid cancellous bone screw K926047 8.0mm cannulated cancellous bone screw K903811 ACE cannulated cortical bone screw…
Ace Orthopedic Manufacturing Co.1993—
*K903811Ace Cannulated Cortical Bone Screw
Summary page 2
…K954485 6.5mm solid cancellous bone screw K926047 8.0mm cannulated cancellous bone screw K903811 ACE cannulated cortical bone screw K903810 ACE cannulated self tapping cancellous bone screw…
Ace Medical Co.1990—
*K903810Ace Cannulated Self Tapping Cancellous Bone Screw
Summary page 2
…K926047 8.0mm cannulated cancellous bone screw K903811 ACE cannulated cortical bone screw K903810 ACE cannulated self tapping cancellous bone screw K874670 ACE Cannulated Self-Tapping cortical bone s…
Ace Medical Co.1990—
*K874670Ace Cannulated Self-Tapping Cortical Bone Screw
Summary page 2
…K903811 ACE cannulated cortical bone screw K903810 ACE cannulated self tapping cancellous bone screw K874670 ACE Cannulated Self-Tapping cortical bone screw K872859 Cancellous bone screw…
Buckman Co., Inc.1987—
*K872859Ace Cancellous Bone Screw
Summary page 2
…K903810 ACE cannulated self tapping cancellous bone screw K874670 ACE Cannulated Self-Tapping cortical bone screw K872859 Cancellous bone screw K895107 Washers K042325 ACE Trochanteric Nail…
Ace Medical Co.1987—
*K895107Ace Orthopaedic Washers
Summary page 2
…K874670 ACE Cannulated Self-Tapping cortical bone screw K872859 Cancellous bone screw K895107 Washers K042325 ACE Trochanteric Nail K033878 Universal Humeral Nail…
Buckman Co., Inc.1989—
*K042325Trochanteric Nail System
Summary page 2
…ulated Self-Tapping cortical bone screw K872859 Cancellous bone screw K895107 Washers K042325 ACE Trochanteric Nail K033878 Universal Humeral Nail K033806 Proximal Hum…
DePuy Orthopaedics, Inc.200411
*K033878Ace Antegrade Retrograde Humeral Nail System
Summary page 2
…K872859 Cancellous bone screw K895107 Washers K042325 ACE Trochanteric Nail K033878 Universal Humeral Nail K033806 Proximal Humeral Nail K033329 Universal an…
Depuy Ace2004—
*K033806Ace Proximal Humeral Nail System
Summary page 2
…K895107 Washers K042325 ACE Trochanteric Nail K033878 Universal Humeral Nail K033806 Proximal Humeral Nail K033329 Universal and Troch Entry Nails K032097 Tib…
Depuy Ace2004—
*K033329Depuy Ace Universal and Troch Entry Femoral Nail Systems
Summary page 2
…25 ACE Trochanteric Nail K033878 Universal Humeral Nail K033806 Proximal Humeral Nail K033329 Universal and Troch Entry Nails K032097 Tibial Nail K023115 VersaNail TTC…
Depuy, Inc.2003—
*K032097Depuy Ace Versanail Tibial Nail
Summary page 2
…al Humeral Nail K033806 Proximal Humeral Nail K033329 Universal and Troch Entry Nails K032097 Tibial Nail K023115 VersaNail TTC Fusion Nail K003797 TTC Fusion Nail…
DePuy Orthopaedics, Inc.2003—
*K023115Ace Versanail
Summary page 2
…806 Proximal Humeral Nail K033329 Universal and Troch Entry Nails K032097 Tibial Nail K023115 VersaNail TTC Fusion Nail K003797 TTC Fusion Nail K060290 Shoulder Fixati…
DePuy Orthopaedics, Inc.2002—
*K003797Ace Aim TTC Fusion Nail
Summary page 2
…Universal and Troch Entry Nails K032097 Tibial Nail K023115 VersaNail TTC Fusion Nail K003797 TTC Fusion Nail K060290 Shoulder Fixation System K060294 Diaphyseal Plate…
DePuy Orthopaedics, Inc.2000—
*K060290Shoulder Fixation System
Summary page 2
…K032097 Tibial Nail K023115 VersaNail TTC Fusion Nail K003797 TTC Fusion Nail K060290 Shoulder Fixation System K060294 Diaphyseal Plate K893512 Cannulated Bone…
Hand Innovations, LLC2006—
*K060294Diaphyseal Plate
Summary page 2
…15 VersaNail TTC Fusion Nail K003797 TTC Fusion Nail K060290 Shoulder Fixation System K060294 Diaphyseal Plate K893512 Cannulated Bone Screw K103001 Rockwood Clavicle…
Hand Innovations, LLC2006—
*K893512Depuy Cannulated Bone Screw
Summary page 2
…K003797 TTC Fusion Nail K060290 Shoulder Fixation System K060294 Diaphyseal Plate K893512 Cannulated Bone Screw K103001 Rockwood Clavicle Pin K041157 Small Bone Fi…
Depuy, Inc.1989—
*K103001Rockwood Clavicle Pins
Summary page 2
…60290 Shoulder Fixation System K060294 Diaphyseal Plate K893512 Cannulated Bone Screw K103001 Rockwood Clavicle Pin K041157 Small Bone Fixation System K960385 Kirschne…
DePuy Orthopaedics, Inc.2011—
*K041157Modification to Small Bone Fixation System
Summary page 2
…K060294 Diaphyseal Plate K893512 Cannulated Bone Screw K103001 Rockwood Clavicle Pin K041157 Small Bone Fixation System K960385 Kirschner Wires & Steinmiann Pins Indications for Use Th…
Hand Innovations, Inc.2004—
*K960385Sterile Kirschner Wires and Steinmann Pins
Summary page 2
…annulated Bone Screw K103001 Rockwood Clavicle Pin K041157 Small Bone Fixation System K960385 Kirschner Wires & Steinmiann Pins Indications for Use The indications for use remain unchanged from the existing cleara…
Depuy, Inc.1996—

Also cleared against K103408: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 14, 2022Class IIZ-0811-2022Under Investigation by firmPackaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find…
Dec 20, 2017Class IIZ-1233-2018Device DesignZimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for…
Dec 20, 2017Class IIZ-1226-2018Device DesignZimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for…
Dec 20, 2017Class IIZ-1227-2018Device DesignZimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for…
Dec 20, 2017Class IIZ-1231-2018Device DesignZimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for…
Dec 20, 2017Class IIZ-1234-2018Device DesignZimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for…
Dec 20, 2017Class IIZ-1229-2018Device DesignZimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for…
Dec 20, 2017Class IIZ-1225-2018Device DesignZimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for…
Dec 20, 2017Class IIZ-1228-2018Device DesignZimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for…
Dec 20, 2017Class IIZ-1230-2018Device DesignZimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for…
Dec 20, 2017Class IIZ-1232-2018Device DesignZimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for…
Dec 20, 2017Class IIZ-1235-2018Device DesignZimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for…
Oct 25, 2017Class IIZ-1306-2018Unknown/Undetermined by firmThe drill guides were manufactured with the incorrect color anodization.
Apr 1, 2016Class IIZ-1817-2016Equipment maintenanceInsufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it…
Nov 20, 2015Class IIZ-0450-2016Process change controlThese screws have a single lead (instead of a triple lead) thread. The screw may sit proud in the plate, If the screw does not lock into the plate; the screw may back out. If the screw sits proud, soft tissue irritation may occur. If the…
Jun 4, 2015Class IIZ-2046-2015Process change controlThe thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are too deep on one side and too shallow on the other. The locking screw may back out of the plate if it does not achieve proper…
Jun 4, 2015Class IIZ-2058-2015PackagingSterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
  • 23 of the 96 ancestors have a recall of any class.
  • Of its descendants, K243761 (Biomet Orthopedics, 2025) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K103408.

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?

Intended for use in intramedullary fixation of supracondylar fractures of the femur, including those with severe comminution and intraarticular involvement, osteoporosis, nonunions, malunions, pathologic and fractures proximal to total knee arthroplasty or prosthesis. The TTC Fusion Nail is also indicated for use in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: revision after failed ankle…

Read the full statement (1,814 words)

Intended for use in intramedullary fixation of supracondylar fractures of the femur, including those with severe comminution and intraarticular involvement, osteoporosis, nonunions, malunions, pathologic and fractures proximal to total knee arthroplasty or prosthesis. The TTC Fusion Nail is also indicated for use in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: revision after failed ankle arthrodesis with subtalar involvement, absent talus (tibio calcaneal arthrodesis); post traumatic/primary arthrosis involving both ankle and subtalar joints; a rheumatoid hindfoot; avascular necrosis of the talus; previously infected arthrosis, second degree; failed total arthroplasty.

Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 -21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

Intended for use in tibiocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: revision after failed ankle arthrodesis with subtalar involvement; absent talus (tibiocalcaneal arthrodesis); post traumatic or primary arthrosis involving both ankle and subtalar joints; rheumatoid hindfoot; avascular necrosis of the talus; previously infected arthrosis, second degree; failed total ankle arthroplasty. Indications also include non-union ankle arthrodesis; osteoarthritis; post-traumatic and degenerative arthritis; neuroarthropathy or neuropathic ankle deformity; neuromuscular disease with severe deformity and Charcot foot.

* Fixation of metaphyseal fractures of the distal tibia

* Proximal metaphyseal tibial fractures

* Calcaneus fractures

* Proximal humeral head/shaft fractures

* Distal femur fracture - comminuted shaft fractures

* Fixation of soft tissue, such as tendon and ligaments, to bone

Small bone plates (3.5mm):

For intra-articular distal tibial fractures and those of the humeral head; for fractures of the fibula, lateral malleolus, metatarsals and metacarpals, olecranon and distal humerus; for application to the palmar surface of the distal radius and fractures of the olecranon and distal tibia; for application to the dorsum of the distal radius; fractures of the calcaneus; fractures of the radius and ulna; for pelvic and acetabular reconstructive surgery

Large bone plates (4.5, 6.5mm):

For use on the tibia, femur and humerus; for use on the anterior aspect of the distal tibia; for use as a tension band on the proximal humerus and as a buttress on the medial tibial plateau; for use as a buttress on the lateral tibial plateau; for use on fractures of the pelvis and acetabulum; for fractures of the distal humerus; for use as a tension band plate on the radius, ulna and fibula

Pilon fractures: distal tibial intraarticular fractures, high medial malleolar fractures, low boot, type rotational distal extraarticular shaft fractures.

Distal intra-articular tibia fractures; proximal tibia fractures; proximal and distal humerus fractures

Fractures of the fibula, lateral malleolus, metatarsals and metacarpals, olecranon, distal humerus and humeral head; application to the dorsum of the distal radius; fractures of the radius and ulna; intra-articular distal tibial fractures

The 3.5mm plate may be used for fractures of the clavicle, scapula, distal humerus, acetabulum and pelvis.

The 4.5mm plate is intended for use in the following types of fractures: pelvic fractures and acetabular fractures.

For fixation of fractures, fusions, osteotomies and non-unions of the clavicle, humerus, radius, ulna, olecranon, metacarpal, metatarsal, malleolus, tibia, fibula, particularly in osteopenic bone

Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

Intended for treatment of nonunions, osteotomies, malunions, osteopenic bone and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic and fractures with associated shaft fractures.

For stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.

Intended for fixation of fractures and osteotomies involving the distal radius

For fixation of fractures, osteotomies and non-unions of the fibula, malleolus, metatarsals and metacarpals, olecranon, clavicle, scapula, distal humerus and humeral head, radius, ulna and distal tibia, particularly in osteopenic bone.

The Medial Locking Plate is indicated for pilon fractures: distal tibial intraarticular fractures, high medial malleolar fractures, low boot type rotational distal extraarticular shaft fractures.

The Anterolateral Locking Plates are indicated for distal intraarticular tibia fractures, proximal tibia fractures and proximal and distal humerus fractures.

Fixation of various long bones, such as the humerus, femur and tibia. Also for use in fixation of osteopenic bone and fixation and stabilization of non-unions, malunions and osteotomies.

Intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone

Intended for essentially non load bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton.

Intended for use in cases requiring stabilization of malunions, non-unions, and osteotomies of the distal femur and proximal tibia and Open Reduction Internal Fixation (ORIF) repair of closed and open fractures of the distal femur and proximal tibia including, but not limited to the following: periarticular fractures, such as simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression fractures with associated shaft fractures, and periprosthetic fractures.

Intended for the fixation of fractures and osteotomies involving the distal radius

Intended for the fixation of fractures and osteotomies involving the distal radius

Intended for use in fracture fixation cases requiring open reduction internal fixation (ORIF) for closed and open fractures of the distal femur and proximal tibia including repair of non-unions, malunions and fractures including but not limited to simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures

Designed to assist the surgeon in the management of intra-articular fractures of the calcaneus, extra-articular fractures of the calcaneus

Indicated for fractures of the proximal femur extending from the subcapital area to the level of the lesser trochanter, as well as proximal femoral osteotomies. Appropriate utilization of this device ultimately depends on the surgical judgment surrounding each patient's particular situation.

Internal fixation of hip fractures

Internal fixation of hip fractures

Internal fixation of hip fractures

Indications for use of this device shall include fixation of the pelvis and of the long bones, including the femur, tibia, ulna, radius, humerus and fibula.

Fracture fixation of long bones (femur, tibia, subcapital fracture of the hip, pelvic ring, acetabulum, foot and ankle and os calcis, olecranon)

For plating of maxillofacial fractures or for other small bone fractures (fracture fixation) as determined by the surgeon

Fracture fixation of long bones

Fracture fixation of long bones

General orthopaedic conditions and fractures that would benefit from the use of cannulated self-tapping cortical bone screws

Internal fixation of hip fractures and for additional orthopaedic indications such as condylar fractures of the distal femur and/or selected fractures of the tibial plateau.

Intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus

Intended for use over a guide pin for fracture fixation in cancellous bone. The cannulated screw is intended to be inserted into pre-drilled bone.

Intended for bone fixation in the management of fracture and reconstructive surgeries.

Non-weight bearing bone fixation is indicated in the following conditions:

" Transverse, oblique, spiral, segmental and comminuted fractures;

* Fractures with bone loss and bone transport;

* Open fractures, pathologic fractures;

* Corrective osteotomies;

* Pseudarthrosis of the tibial shaft;

* Nonunions, malunions, metaphyseal and epiphyseal fractures.

Intended to be used in conjunction with bone screws

Intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions and malunions and revision procedures.

Indicated for open and closed fracture patterns, humeral shaft fractures, fractures of the proximal and distal metaphysis, comminuted fractures of the humerus with small medullary canals, fracture non-unions and mal-unions, pathological fractures, floating elbow.

Intended for the fixation of proximal humeral fractures. These implants are intended as a guide to normal healing and are not intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.

Intended to treat proximal, middle and distal third fractures, severely comminuted shaft fractures extending beyond the isthmus, spiral, long oblique and segmental fractures, non-unions and malunions, lengthening of the bone, fractures with bone loss, bi-lateral fractures, pseudoarthrosis of the femoral shaft, supracondylar fractures, subtrochanteric fractures, with or without involvement of lesser trochanter, subtrochanteric/intertrochanteric combination fractures, ipsilateral femoral shaft and neck fractures, stable and unstable proximal fractures of the femur, including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, pertrochanteric features associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, proximal or distal non-unions and malunions, leg length discrepancies secondary to femoral inequality, femur reconstruction following tumor resection, stable femoral fractures without necessity for interlocking, long subtrochanteric fractures, and revision procedures involving the replacement of implanted hardware. In addition to the above indications, the Universal NAIL, when used in the retrograde mode, is also indicated for treatment of femoral shaft fractures in obese or multiple trauma patients and supracondylar fractures, including those with severe, extra-articular comminution and/or intra-articular involvement, osteoporosis, non-unions, malunions, pathologic fractures, and those proximal to total knee prosthesis.

Intended to be used to repair an acute fracture, malunion or non-union of the clavicle.

For the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges, and the metatarsal bones of the foot.

Fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K111663: Trauma Internal Fixation Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K111663

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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