510(k) · Cleared
ClearedTempo Plating System; Ultra Compression Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pace Surgical · HRS Plate, Fixation, Bone
Cleared on Sep 3, 2026 as substantially equivalent to K250952 (Paragon 28, Inc., 2025) and 2 other predicates after a 107-day review. Its family tree reaches back 16 generations to 1996.
- Decided
- Sep 3, 2026
- Review
- 107 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K962616 (1996). 132 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 16 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 12 generations between
- 3 generations backK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- 2 generations backK203011 Monster Screw SystemParagon 28, Inc. · 2020
- 1 generation backK251555 Ultra™ Compression Screw SystemPace Surgical · 2025
- This deviceK261647 Tempo Plating System; Ultra Compression Screw SystemPace Surgical · 2026
Show all 16 generations
- Root · 16 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 15 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 14 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 13 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 12 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 11 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 10 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 9 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 8 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 7 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 6 generations backK124027 Monster Screw SystemApogee Orthosolutions · 2013
- 5 generations backK151418 Monster Screw SystemParagon 28 · 2015
- 4 generations backK153378 Monster BITE Screw SystemParagon 28 · 2015
- 3 generations backK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- 2 generations backK203011 Monster Screw SystemParagon 28, Inc. · 2020
- 1 generation backK251555 Ultra™ Compression Screw SystemPace Surgical · 2025
- This deviceK261647 Tempo Plating System; Ultra Compression Screw SystemPace Surgical · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −15 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −14 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −13 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −12 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −11 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −10 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −9 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −8 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −7 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −6 | K124027 | Monster Screw System | Apogee Orthosolutions | 2013 | — |
| −5 | K151418 | Monster Screw System | Paragon 28 | 2015 | — |
| −4 | K153378 | Monster BITE Screw System | Paragon 28 | 2015 | — |
| −3 | K190586 | Monster® Screw System | Paragon 28, Inc. | 2019 | — |
| −2 | K203011 | Monster Screw System | Paragon 28, Inc. | 2020 | — |
| −1 | K251555 | Ultra™ Compression Screw System | Pace Surgical | 2025 | — |
| 0 (this device) | K261647 | Tempo Plating System; Ultra Compression Screw System | Pace Surgical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 6 | 0 |
| 1996 | 11 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 10 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K250952 | Baby Gorilla®/Gorilla® Plating SystemSummary page 7…threaded metallic bone fixation fastener Panel: Orthopedic Product Code: HRS (Primary), HWC Predicate Devices: K250952, Baby Gorilla®/Gorilla® Plating System (Primary) K251555, Ultra™ Compression Screw System… | 2025 |
| * | K251555 | Ultra™ Compression Screw SystemSummary page 7…ct Code: HRS (Primary), HWC Predicate Devices: K250952, Baby Gorilla®/Gorilla® Plating System (Primary) K251555, Ultra™ Compression Screw System K203011, Monster Screw System Device Description: The Pace Sur… | 2025 |
| * | K203011 | Monster Screw SystemSummary page 7…K250952, Baby Gorilla®/Gorilla® Plating System (Primary) K251555, Ultra™ Compression Screw System K203011, Monster Screw System Device Description: The Pace Surgical Tempo Plating System is a plating system designed for fixation of bo… | 2020 |
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 30 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 28 of the 132 ancestors have a recall of any class.
- 1 other device also cites its predicate K250952.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Tempo Plating System is indicated for use in stabilization and fixation of fractures or osteotomies; intra- and extra-articular fractures, joint depression, and multifragmentary fractures; revision procedures, joint fusion, and reconstruction of small bones of the toes, feet, and ankles, including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists. The system can be used in adult patients. Specific examples include…
Read the full statement (472 words)
The Tempo Plating System is indicated for use in stabilization and fixation of fractures or osteotomies; intra- and extra-articular fractures, joint depression, and multifragmentary fractures; revision procedures, joint fusion, and reconstruction of small bones of the toes, feet, and ankles, including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists. The system can be used in adult patients. Specific examples include:
Forefoot:
• Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
• Metatarsal or phalangeal fractures and osteotomies
• Lesser metatarsal fractures (e.g. Weil)
• Fifth metatarsal fractures (e.g. Jones Fracture)
M id/H indfoot:
• LisFranc Arthrodesis and/or Stabilization
• 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
• lntercuneiform Fusions
• Navicular-Cuneiform (NC) Fusion
• Talo-Navicular (TN) Fusion
• Calcaneo-Cuboid (CC) Fusion
• Subtalar Fusion
• Medial Column Fusion
• Cuneiform Fracture
• Cuboid Fracture
• Navicular Fracture
First metatarsal osteotomies for hallux valgus correction, including:
• Opening base wedge osteotomy
• Closing base wedge osteotomy
• Crescentic Osteotomy
• Proximal Osteotomy (Chevron and Rotational Oblique)
• Distal Osteotomy (Chevron / Austin)
Arthrodesis of the first metatarsophalangeal joint (MTP), including:
• Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
• Revision MTP Fusion
• Revision of failed first MTP Arthroplasty implant
Flatfoot:
• Lateral Column Lengthing (Evans Osteotomy)
• Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
• Calcaneal Slide Osteotomy
Charcot:
• Medial column fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot)
• Lateral column fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot)
In addition, the non-locking screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.
The Pace Surgical Ultra r M Compression Screw System is intended for the internal fixation and stabilization of arthrodeses, osteotomies, fractures, and nonunions of the foot and ankle. The System is specifically indicated for:
Fractures and Osteotomies
• Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc)
• Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture)
• T alar fractures
• Ankle fractures
• Navicular fractures
• Fractures of the fibula, malleolus, and calcaneus
• Metatarsal and phalangeal osteotomies
• Weil osteotomy
• Calcaneal osteotomy
Fusion resulting from neuropathic osteoarthropathy (Charcot), example:
• Medial and lateral column
• Subtalar, talonavicular, and calcaneocuboid
Arthrodesis and Deformity Correction
• 1st MTP arthrodesis
• Metatarsal deformity correction
• Tarsometatarsal joint arthrodesis
• Naviculocuneiform joint arthrodesis
• T alonavicular arthrodesis
• Subtalar joint arthrodesis
• Triple arthrodesis
• Medial column arthrodesis
• Subtalar joint distraction arthrodesis
• Ankle arthrodesis
• Lateralizing calcaneal osteotomy
• Lateral column lengthening
• Hammertoe
Hallux Valgus Correction
• Fixation of osteotomies (i.e. Akin, Scarf, Chevron)
• lnterphalangeal (IP) arthrodesis
• Proximal, midshaft, or distal osteotomy
• Laoidus arthrodesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261647: Tempo Plating System; Ultra Compression Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261647
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026