510(k) · Cleared
Recalled · Class II · 2022Trauma Internal Fixation Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
- Root · 7 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 5 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 4 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 2 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 1 generation backK060864 Multidirectional Threaded PegHand Innovations, LLC · 2006
- This deviceK111663 Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012
- 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −6 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −5 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −4 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −2 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −1 | K060864 | Multidirectional Threaded Peg | Hand Innovations, LLC | 2006 | — |
| 0 (this device) | K111663 | Trauma Internal Fixation Systems | DePuy Orthopaedics, Inc. | 2012 | — |
| +1 | K243761 | A.L.P.S. Small Fragment Plating System | Biomet Orthopedics | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 7 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103408 | Posterior Lateral PlatesSummary 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… | 2010 |
| * | K101421 | Medical 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… | 2010 |
| * | K082300 | Anatomic Locking Plating SystemSummary 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… | 2009 |
| * | K093474 | Depuy Fracture and Fusion Plating SystemSummary 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… | 2010 |
| * | K091294 | Lateral 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… | 2009 |
| * | K101240 | Closed 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… | 2010 |
| * | K090877 | Proximal 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… | 2009 |
| * | K090492 | 1.5MM Small Locking Plate, 1.5MM Non-Locking and Locking ScrewsSummary 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… | 2009 |
| * | K083364 | 2.5 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… | 2008 |
| * | K081546 | Small Bone Locking Plating SystemSummary 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… | 2008 |
| * | K090374 | Sterile 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… | 2009 |
| * | K083843 | Locking Anatomic & Composite Plating SystemSummary 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… | 2009 |
| * | K072832 | Anterolateral and Medial Locking Plating SystemSummary 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… | 2007 |
| * | K072423 | 4.5MM 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… | 2007 |
| * | K072083 | Small Fragment Locking Plating SystemSummary 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… | 2007 |
| * | K061748 | Fragment Plate SystemSummary 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… | 2006 |
| * | K060969 | Polyax Locked Plating SystemSummary 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… | 2006 |
| * | K050932 | Distal Volar Radius Anatomical Plate SystemSummary 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… | 2005 |
| * | K003235 | PE.R.I. II Knee Fracture SystemSummary page 2…9 Traditional 510(k) K111663 aoeIF K003235 PERt 11Knee Fracture System K993465, K981775 Calcaneal Peri-Articular Plate… | 2000 |
| * | K993465 | Depuy Ace Calcaneal Peri-Articular PlateSummary page 2…aoeIF K003235 PERt 11Knee Fracture System K993465, K981775 Calcaneal Peri-Articular Plate K990392 DePuy ACE Spider Plate K9… | 2000 |
| * | K981775 | Depuy Ace Timax Calcaneal Peri-Articular PlateSummary page 2…aoeIF K003235 PERt 11Knee Fracture System K993465, K981775 Calcaneal Peri-Articular Plate K990392 DePuy ACE Spider Plate K990120 DeP… | 1998 |
| * | K990392 | Depuy Ace Spider PlateSummary 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… | 1999 |
| * | K990120 | Modification of Depuy Ace Timax Medial Pilon PlateSummary 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… | 1999 |
| * | K983853 | Depuy Ace Timax Meta Plate | 1998 |
| * | K972629 | Depuy AE TK2 Hip Screw SystemSummary 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… | 1997 |
| * | K970503 | Depuy Ace Trochanteric Side PlateSummary 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… | 1997 |
| * | K950618 | Ace Supracondylar PlateSummary 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… | 1995 |
| * | K813554 | Ace/Kyle Captured Hip ScrewSummary 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… | 1982 |
| * | K930592 | Ace Universal Reconstruction PlateSummary 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… | 1993 |
| * | K920738 | Ace 100 Degrees Tubular PlateSummary page 2…Plate, Supracondylar Plate, Captured Hip Screw K930592 Universal Reconstruction Plate K920738 ACE 100 Degree Tubular Plate K905774 Titanium Mini-Plating System K905595… | 1992 |
| * | K905774 | Thackray Titanium Mini-Plating SystemSummary 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… | 1991 |
| * | K905595 | Ace Reconstructive PlateSummary 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.… | 1991 |
| * | K060864 | Multidirectional Threaded PegSummary 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… | 2006 |
| * | K954485 | 6.5MM Solid Cancellous Bone ScrewSummary 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… | 1995 |
| * | K926047 | Ace 8.0MM Cannulated Cancellous Bone ScrewSummary 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… | 1993 |
| * | K903811 | Ace Cannulated Cortical Bone ScrewSummary 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… | 1990 |
| * | K903810 | Ace Cannulated Self Tapping Cancellous Bone ScrewSummary 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… | 1990 |
| * | K874670 | Ace Cannulated Self-Tapping Cortical Bone ScrewSummary 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… | 1987 |
| * | K872859 | Ace Cancellous Bone ScrewSummary 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… | 1987 |
| * | K895107 | Ace Orthopaedic WashersSummary page 2…K874670 ACE Cannulated Self-Tapping cortical bone screw K872859 Cancellous bone screw K895107 Washers K042325 ACE Trochanteric Nail K033878 Universal Humeral Nail… | 1989 |
| * | K042325 | Trochanteric Nail SystemSummary 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… | 2004 |
| * | K033878 | Ace Antegrade Retrograde Humeral Nail SystemSummary page 2…K872859 Cancellous bone screw K895107 Washers K042325 ACE Trochanteric Nail K033878 Universal Humeral Nail K033806 Proximal Humeral Nail K033329 Universal an… | 2004 |
| * | K033806 | Ace Proximal Humeral Nail SystemSummary page 2…K895107 Washers K042325 ACE Trochanteric Nail K033878 Universal Humeral Nail K033806 Proximal Humeral Nail K033329 Universal and Troch Entry Nails K032097 Tib… | 2004 |
| * | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsSummary 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… | 2003 |
| * | K032097 | Depuy Ace Versanail Tibial NailSummary 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… | 2003 |
| * | K023115 | Ace VersanailSummary 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… | 2002 |
| * | K003797 | Ace Aim TTC Fusion NailSummary 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… | 2000 |
| * | K060290 | Shoulder Fixation SystemSummary page 2…K032097 Tibial Nail K023115 VersaNail TTC Fusion Nail K003797 TTC Fusion Nail K060290 Shoulder Fixation System K060294 Diaphyseal Plate K893512 Cannulated Bone… | 2006 |
| * | K060294 | Diaphyseal PlateSummary 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… | 2006 |
| * | K893512 | Depuy Cannulated Bone ScrewSummary 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… | 1989 |
| * | K103001 | Rockwood Clavicle PinsSummary page 2…60290 Shoulder Fixation System K060294 Diaphyseal Plate K893512 Cannulated Bone Screw K103001 Rockwood Clavicle Pin K041157 Small Bone Fixation System K960385 Kirschne… | 2011 |
| * | K041157 | Modification to Small Bone Fixation SystemSummary 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… | 2004 |
| * | K960385 | Sterile Kirschner Wires and Steinmann PinsSummary 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… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243761 | A.L.P.S. Small Fragment Plating System | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 14, 2022 | Class II | Z-0811-2022 | Under Investigation by firm | Packaging 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, 2017 | Class II | Z-1233-2018 | Device Design | Zimmer 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, 2017 | Class II | Z-1226-2018 | Device Design | Zimmer 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, 2017 | Class II | Z-1227-2018 | Device Design | Zimmer 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, 2017 | Class II | Z-1231-2018 | Device Design | Zimmer 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, 2017 | Class II | Z-1234-2018 | Device Design | Zimmer 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, 2017 | Class II | Z-1229-2018 | Device Design | Zimmer 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, 2017 | Class II | Z-1225-2018 | Device Design | Zimmer 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, 2017 | Class II | Z-1228-2018 | Device Design | Zimmer 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, 2017 | Class II | Z-1230-2018 | Device Design | Zimmer 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, 2017 | Class II | Z-1232-2018 | Device Design | Zimmer 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, 2017 | Class II | Z-1235-2018 | Device Design | Zimmer 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, 2017 | Class II | Z-1306-2018 | Unknown/Undetermined by firm | The drill guides were manufactured with the incorrect color anodization. |
| Apr 1, 2016 | Class II | Z-1817-2016 | Equipment maintenance | Insufficient 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, 2015 | Class II | Z-0450-2016 | Process change control | These 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, 2015 | Class II | Z-2046-2015 | Process change control | The 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, 2015 | Class II | Z-2058-2015 | Packaging | Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection. |
The 5 latest of 17 recalls; the web page lists all.
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 devicesHRS 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
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
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.
https://510kreport.com/device/K111663 · printed Nov 3, 2026
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