510(k) · Cleared
ClearedTrimed Sterile Product
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
TriMed, Inc. · HRS Plate, Fixation, Bone
Cleared on Jul 15, 2009 as substantially equivalent to K951302 (Medpac, 1995) and 6 other predicates after an 85-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Jul 15, 2009
- Review
- 85 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K962616 (1996). 55 ancestors in all, the oldest K890939 (1989). No later device cites it as a predicate yet.
- Root · 8 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 6 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 5 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 2 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 1 generation backK060041 Trimed Bone PlatesTriMed, Inc. · 2006 · Recalled
- This deviceK091156 Trimed Sterile ProductTriMed, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −7 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −6 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −5 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −2 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −1 | K060041 | Trimed Bone Plates | TriMed, Inc. | 2006 | 3 |
| 0 (this device) | K091156 | Trimed Sterile Product | TriMed, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2008 | 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? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951302 | Small Fragment Plates and ScrewsSummary page 1…Class II: Pin, Fixation, Smooth HTY - Section 888.3040 510(K)'s Being Modified: K951302 - TriMed, Inc. (Formerly MEDPAC) Small Fragment Pla… | 1995 |
| * | K951303 | SFCSummary page 1…nc. (Formerly MEDPAC) Small Fragment Plates & Screws K951303 - TriMed, Inc. (Formerly MEDPAC) SFC… | 1995 |
| * | K010545 | TBWSummary page 1…K951303 - TriMed, Inc. (Formerly MEDPAC) SFC K010545 - TriMed, Inc. TBW I of 2… | 2001 |
| * | K040112 | Trimed Bearing Plate; Trimed Volar Bearing PlateSummary page 2…I of 2 Confidential 510(K)'s Being Modified (cont'd): K040112 - TriMed, Inc. Bearing & Volar Bearing Plate… | 2004 |
| * | K043263 | Trimed Osteotomy PlateSummary page 2…K040112 - TriMed, Inc. Bearing & Volar Bearing Plate K043263 - TriMed, Inc. Osteotomy Plate… | 2005 |
| * | K060041 | Trimed Bone PlatesSummary page 2…K043263 - TriMed, Inc. Osteotomy Plate K060041 - TriMed, Inc. Bone Plates… | 2006 |
| * | K081348 | Tenodesis Cross Screw, Interference Screw, Suture BeadSummary page 2…K060041 - TriMed, Inc. Bone Plates K081348 - TriMed, Inc. Tenodesis Cross Screw, Interference… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 10 of the 55 ancestors have a recall of any class.
- 2 other devices also cite its predicate K951302.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Used as an aid to the healing of volar rim fractures of the distal radius. Used as an aid to the treatment of certain types of fractures involving small fragments. Specifically: - Cortical fragments large and strong enough to allow application of the device with fixation to an adjacent stable cortex of cortical bone. - An intraarticular fragment large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone. -A…
Read the full statement (383 words)
Used as an aid to the healing of volar rim fractures of the distal radius.
Used as an aid to the treatment of certain types of fractures involving small fragments. Specifically:
- Cortical fragments large and strong enough to allow application of the device with fixation to an adjacent stable cortex of cortical bone.
- An intraarticular fragment large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone.
-A combination of the above
Skeletal fractures that are amenable to the principle of tension band wiring. Typical sites of application may include but are not limited to fractures of the olecranon, patella, medial malleolus, lateral malleolus, distal ulna, distal humerus, and proximal humerus. The decision to use a specific implant as well as the size and shape of the implant used must be based on sound medical judgement that takes into consideration factors such as the circumstances and configuration of-the injury.
1. Fixation of fractures or non-unions of the distal radius
2. Osteotomies of the distal radius to correct malunion.
The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.
The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.
The TriMed Tenodesis Cross Screw and Interference Screw are intended to be used as an aid for fixation of soft tissue grafts to bone. Specific indications for use include:
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, Tendon Transfer in the hand and wrist.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruciton, Tendon Transfers in the foot and ankle.
The TriMed Suture Bead is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting. The Suture Beads are also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment.
The TriMed Suture Bead is not indicated for use within intra-articular sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091156 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091156: Trimed Sterile Product.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091156
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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