510(k) · Cleared
ClearedSmple Plate and Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Trauma (Aka Ebi, Lp) · HRS Plate, Fixation, Bone
Cleared on Mar 19, 2010 as substantially equivalent to K082807 (Synthes (Usa), 2008) and 3 other predicates after an 85-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Mar 19, 2010
- Review
- 85 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K962616 (1996). 41 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 backK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
- This deviceK093983 Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp) · 2010
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 | K083286 | Orthopediatrics Pediloc Locking Plate System | OrthoPediatrics Corp. | 2009 | 5 |
| 0 (this device) | K093983 | Smple Plate and Screws | Biomet Trauma (Aka Ebi, Lp) | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 4 | 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? (4)
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 |
|---|---|---|---|
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 2…and does not present any new issues of safety or effectiveness. Examples of predicates include: Synthes 3.5 and 4.5 Locking Compression Plates for expanded indications (K082807); Orthopediatrics PediLocTM Plating Systems (K083286) and the Biomet IQL Plating System (K020221), and the Biomet OptiLock® Peria… | 2008 |
| * | K083286 | Orthopediatrics Pediloc Locking Plate SystemSummary page 2…ectiveness. Examples of predicates include: Synthes 3.5 and 4.5 Locking Compression Plates for expanded indications (K082807); Orthopediatrics PediLocTM Plating Systems (K083286) and the Biomet IQL Plating System (K020221), and the Biomet OptiLock® Periarticular Plating System (K06 1098). Based upon the en… | 2009 |
| * | K020221 | Iql Basic Fragment Plate Set, Iql Basic Fragment Screw Set, Iql Small Fragment Set, Iql…Summary page 2…Synthes 3.5 and 4.5 Locking Compression Plates for expanded indications (K082807); Orthopediatrics PediLocTM Plating Systems (K083286) and the Biomet IQL Plating System (K020221), and the Biomet OptiLock® Periarticular Plating System (K06 1098). Based upon the engineering analysis and the other information… | 2002 |
| * | K061098 | Ebi Optilock Periarticular Plating SystemSummary page 2…ations (K082807); Orthopediatrics PediLocTM Plating Systems (K083286) and the Biomet IQL Plating System (K020221), and the Biomet OptiLock® Periarticular Plating System (K06 1098). Based upon the engineering analysis and the other information presented in this premarket notification, the SMPIe Th Pediatric… | 2006 |
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 14 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 41 ancestors have a recall of any class.
- 42 other devices also cite its predicate K082807.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The SMPle™ Pediatric Submuscular Plating System is intended for adult or pediatric patients as indicated for long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity, malunions, non-union or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, and radius. In pediatric femoral applications, the SMPle™ Pediatric Submuscular Plating System…
Read the full statement (116 words)
The SMPle™ Pediatric Submuscular Plating System is intended for adult or pediatric patients as indicated for long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity, malunions, non-union or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, and radius.
In pediatric femoral applications, the SMPle™ Pediatric Submuscular Plating System is intended for use in the treatment of femoral fractures, malunions or non-unions, femoral osteotomies required for the correction of deformity, and arthrodesis. Indications for buttressing multi-fragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093983: Smple Plate and Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093983
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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