510(k) Report

510(k) · Cleared

Cleared

ORTHOLOC SPS Shoulder Plating System

K181587510(k) TraditionalCleared Oct 5, 2018112-day reviewClass II21 CFR 888.3030

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

Tornier, Inc. · HRS Plate, Fixation, Bone

Cleared on Oct 5, 2018 as substantially equivalent to K011815 (Synthes (Usa), 2001) and 7 other predicates after a 112-day review. Its family tree reaches back 3 generations to 2010. 1 later device descends from it.

Decided
Oct 5, 2018
Review
112 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
8

Its longest line of descent runs back 3 generations to K100146 (2010). 9 ancestors in all, the oldest K983495 (1998). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2004: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor1998: 1 other ancestor2019: 1 descendant clearedK100146 · Evolve Eps Ortholoc · Wrightmedicaltechnologyinc · 2010K102352 · Evolve Eps Ortholoc · Wrightmedicaltechnologyinc · 2010K111432 · Evolve (R) Triad (TM) Plating System and Evolve (R) Triad (TM) Bone Screws · Wrightmedicaltechnologyinc · 20111995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant K111432 · Evolve (R) Triad (TM) Plating System and Evolve (R) Triad (TM) Bone Screws · Wrightmedicaltechnologyinc · 2011K102352 · Evolve Eps Ortholoc · Wrightmedicaltechnologyinc · 2010K100146 · Evolve Eps Ortholoc · Wrightmedicaltechnologyinc · 20100
  1. Root · 3 generations backK100146 Evolve Eps OrtholocWrightmedicaltechnologyinc · 2010
  2. 2 generations backK102352 Evolve Eps OrtholocWrightmedicaltechnologyinc · 2010
  3. 1 generation backK111432 Evolve (R) Triad (TM) Plating System and Evolve (R) Triad (TM) Bone…Wrightmedicaltechnologyinc · 2011
  4. This deviceK181587 ORTHOLOC SPS Shoulder Plating SystemTornier, Inc. · 2018
  5. Descendant · cites it directly · 0 of its ownK191711 ORTHOLOC™ SPS Shoulder Plating SystemTornier, Inc. · 2019

Most influential descendants

Showing 1 of 1 · See all
  • K191711ORTHOLOC™ SPS Shoulder Plating SystemTornier, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K100146Evolve Eps OrtholocWrightmedicaltechnologyinc2010—
−2K102352Evolve Eps OrtholocWrightmedicaltechnologyinc2010—
−1K111432Evolve (R) Triad (TM) Plating System and Evolve (R) Triad (TM) Bone ScrewsWrightmedicaltechnologyinc2011—
0 (this device)K181587ORTHOLOC SPS Shoulder Plating SystemTornier, Inc.2018—
+1K191711ORTHOLOC™ SPS Shoulder Plating SystemTornier, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200010
200120
200410
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
FIG. 1 — Lineage of K181587, 2010–2019Source: 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? (8)

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
*K011815Synthes LCP Proximal Humerus Plates
Summary page 4
…ances and accessories Regulatory Class: II Regulation Number: 888.3030 Product Code: HRS, HWC Predicate Device Information Primary Predicate: K011815, SYNTHES LCP PROXIMAL HUMERUS PLATES Additional Predicates: K000684, SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING…
Synthes (Usa)2001—
*K000684Small Fragment Dynamic Compression Locking (DCL) System
Summary page 4
…888.3030 Product Code: HRS, HWC Predicate Device Information Primary Predicate: K011815, SYNTHES LCP PROXIMAL HUMERUS PLATES Additional Predicates: K000684, SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM K011335, SYNTHS ONE-THIRD…
Synthes (Usa)20001
*K011335Synths One-Third Tubular DCL Plate
Summary page 4
…YNTHES LCP PROXIMAL HUMERUS PLATES Additional Predicates: K000684, SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM K011335, SYNTHS ONE-THIRD TUBULAR DCL PLATE K041860, SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG…
Synthes (Usa)20012
*K041860Synthes (Usa) LCP Proximal Humerus Plates, Long
Summary page 4
…SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM K011335, SYNTHS ONE-THIRD TUBULAR DCL PLATE K041860, SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG K082625, SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL…
Synthes (Usa)2004—
*K082625Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus Plates
Summary page 4
…K011335, SYNTHS ONE-THIRD TUBULAR DCL PLATE K041860, SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG K082625, SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES K100146 and K102352,…
Synthes (Usa)20081
*K100146Evolve Eps Ortholoc
Summary page 4
…PROXIMAL HUMERUS PLATES, LONG K082625, SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES K100146 and K102352, EVOLVE EPS ORTHOLOC K111432, EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R)…
Wrightmedicaltechnologyinc2010—
*K102352Evolve Eps Ortholoc
Summary page 4
…ERUS PLATES, LONG K082625, SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES K100146 and K102352, EVOLVE EPS ORTHOLOC K111432, EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) T…
Wrightmedicaltechnologyinc2010—
*K111432Evolve (R) Triad (TM) Plating System and Evolve (R) Triad (TM) Bone Screws
Summary page 4
…NTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES K100146 and K102352, EVOLVE EPS ORTHOLOC K111432, EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS Device Description ORTHOLOC™…
Wrightmedicaltechnologyinc2011—

Also cleared against K011815: 24 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K191711ORTHOLOC™ SPS Shoulder Plating SystemTornier, Inc.20190

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 8 years and passes through 2 companies; a new generation was cleared every 10 months on median.
  • 3 of the 9 ancestors have a recall of any class.
  • Of its descendants, K191711 (Tornier, Inc., 2019) has gone furthest, with 0 descendants of its own.
  • 24 other devices also cite its predicate K011815.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?

The ORTHOLOC™ SPS is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

Indications for use as stated in the FDA summary.

Also cleared against K011815

24 other devices cite the same predicate.

  • K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG · 2025
  • K233994VOLT™ Proximal Humerus 3.5 Plating SystemSynthes GmbH · 2024
  • K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd. · 2023
  • K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal…Bonebridge AG · 2023
  • K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022
  • K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2020

More from Tornier, Inc.

52 FDA decisions under this applicant name. See the company

  • K260721Tornier Perform Advanced GlenoidTornier, Inc. · 2026
  • K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc. · 2026
  • K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 20251 recall
  • K230352Tornier Humeral Nail and Tornier Long Humeral NailTornier, Inc. · 2023
  • K220914Tornier Perform Humeral System – FractureTornier, Inc. · 2022

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K181587 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181587: ORTHOLOC SPS Shoulder Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181587

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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