510(k) Report

510(k) · Cleared

Cleared

Corin Optimized Positioning System (OPS)

K152893510(k) TraditionalCleared Jun 3, 2016247-day reviewClass II21 CFR 888.3353

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

Corin USA · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Jun 3, 2016 as substantially equivalent to K111863 (Materialise NV, 2012) and 8 other predicates after a 247-day review. Its family tree reaches back 13 generations to 1981. 8 later devices descend from it.

Decided
Jun 3, 2016
Review
247 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
9

Its longest line of descent runs back 13 generations to K810258 (1981). 147 ancestors in all. 8 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 3 other ancestors2012: 2 other ancestors2010: 2 other ancestors2011: 1 other ancestor2009: 2 other ancestors2008: 2 other ancestors2005: 3 other ancestors2004: 9 other ancestors2003: 4 other ancestors2001: 9 other ancestors2000: 16 other ancestors1999: 7 other ancestors2002: 10 other ancestors1997: 11 other ancestors1996: 10 other ancestors1994: 12 other ancestors2006: 1 other ancestor1998: 4 other ancestors1995: 8 other ancestors1993: 4 other ancestors1985: 2 other ancestors1991: 4 other ancestors1988: 1 other ancestor1986: 1 other ancestor1990: 1 other ancestor1984: 1 other ancestor1992: 2 other ancestors1987: 1 other ancestor2018: 1 descendant cleared2020: 5 descendants cleared2019: 1 descendant cleared2021: 1 descendant clearedReference device: K132788 · Myspine Pedicle Screw Placement Guides · Medacta International · 2014K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalled×2: 2 generations cleared close together, K042051 (2005), K051411 (2005) K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K071535 · Biolox Delta Ceramic Femoral Head · Zimmer, Inc. · 2007 · recalledK082844 · Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve · Encore Medical L.P. · 2008 · recalledK100412 · Biolox Delta Ceramic Femoral Heads · Smith & Nephew, Inc. · 2010×2: 2 generations cleared close together, K103120 (2011), K110087 (2011) ×2: 2 generations cleared close together, K122305 (2012), K123705 (2013) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 17 other ancestors3 generations back: 26 other ancestors4 generations back: 29 other ancestors5 generations back: 27 other ancestors6 generations back: 14 other ancestors7 generations back: 12 other ancestors8 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K123705 · Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells · Corin USA · 2013 · recalledK122305 · Corin Trinity-I Acetabular Shell · Corin USA · 2012K110087 · Corin Trinity Acetbular System with Hxlpe Liners · Corin USA · 2011K103120 · Corin Biolox Delta Femoral Heads · Corin USA · 2011K100412 · Biolox Delta Ceramic Femoral Heads · Smith & Nephew, Inc. · 2010K082844 · Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve · Encore Medical L.P. · 2008 · recalledK071535 · Biolox Delta Ceramic Femoral Head · Zimmer, Inc. · 2007 · recalledK061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K051411 · Arcomxl Polyethylene Liners and Biolox Delta Heads · Biomet, Inc. · 2005 · recalledK042051 · Arcomxl Polyethylene Liners · Biomet, Inc. · 2005 · recalledK032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981−10−50
  1. Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 9 generations between
  3. 3 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
  4. 2 generations backK122305 Corin Trinity-I Acetabular ShellCorin USA · 2012
  5. 1 generation backK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
  6. This deviceK152893 Corin Optimized Positioning System (OPS)Corin USA · 2016
  7. Descendant · cites it directly · 5 of its ownK190834 Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA · 2019
  8. Descendant · 2 generations on · 3 of its ownK192656 Optimized Positioning System (OPS) InsightCorin USA · 2020
  9. Descendant · cites it directly · 1 of its ownK181061 Corin Optimized Positioning System (OPS) FemoralCorin USA · 2018
  10. Descendant · 3 generations on · 0 of its ownK210653 ONE Planner HipOrthosoft D/B/A Zimmer Cas · 2021
  11. Descendant · 3 generations on · 0 of its ownK202805 Optimized Positioning System (OPS) InsightCorin USA · 2020
Show all 13 generations
  1. Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 12 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 11 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 10 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 9 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 8 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 7 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
  8. 6 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
  9. 5 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
  10. 4 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
  11. 3 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
  12. 2 generations backK122305 Corin Trinity-I Acetabular ShellCorin USA · 2012
  13. 1 generation backK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
  14. This deviceK152893 Corin Optimized Positioning System (OPS)Corin USA · 2016

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2018: 12019: 12020: 52021: 1
2018high 5 (2020) · low 0 (2022)2026

Most influential descendants

Showing 5 of 8 · See all
  • K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA · 2019 · cites it directly5descendants
  • K192656Optimized Positioning System (OPS) InsightCorin USA · 2020 · 2 generations on3descendants
  • K181061Corin Optimized Positioning System (OPS) FemoralCorin USA · 2018 · cites it directly1descendant
  • K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas · 2021 · 3 generations on0descendants
  • K202805Optimized Positioning System (OPS) InsightCorin USA · 2020 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−12K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−11K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−10K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−9K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−8K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−7K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20073
−6K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset…Encore Medical L.P.20081
−5K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010—
−4K103120Corin Biolox Delta Femoral HeadsCorin USA2011—
−3K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011—
−2K122305Corin Trinity-I Acetabular ShellCorin USA2012—
−1K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA20134
0 (this device)K152893Corin Optimized Positioning System (OPS)Corin USA2016—
+1K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA2019—
+2K192656Optimized Positioning System (OPS) InsightCorin USA2020—
+1K181061Corin Optimized Positioning System (OPS) FemoralCorin USA2018—
+3K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas2021—
+3K202805Optimized Positioning System (OPS) InsightCorin USA2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198520
198610
198710
198810
199010
199140
199220
199340
1994120
199580
1996100
1997110
199840
199970
2000160
200190
2002100
200340
200490
200530
200610
200820
200920
201020
201110
201220
201330

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201910
202050
202110
FIG. 1 — Lineage of K152893, 1981–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 LZO? 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 LZO device

  1. #1 K192827 Quadra-Pscore 19.3 · 10 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? (10)

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
*K111863Signature Planner,Signature Guides
Summary page 5
…Page 2 of 3 9. Legally Marketed Devices to which Substantial Equivalence is claimed: • Materialise N.V. - Signature™ Personalized Patient Care System (K111863) • Corin - Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343, K131647) • Corin In…
Materialise NV2012—
*K093472Trinity Acetabular System
Summary page 3
…ative X- rays and CT imaging scans. The Optimized Positioning System including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty. The Corin Optimized Positioning S…
Corin USA20101
*K110087Corin Trinity Acetbular System with Hxlpe Liners
Summary page 3
…rays and CT imaging scans. The Optimized Positioning System including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty. The Corin Optimized Positioning System is…
Corin USA2011—
*K111481Corin Trinity Acetabular System Ecima Liners
Summary page 3
…CT imaging scans. The Optimized Positioning System including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty. The Corin Optimized Positioning System is intended…
Corin USA20121
*K122305Corin Trinity-I Acetabular Shell
Summary page 3
…g scans. The Optimized Positioning System including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty. The Corin Optimized Positioning System is intended for use w…
Corin USA2012—
*K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells
Summary page 3
…The Optimized Positioning System including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty. The Corin Optimized Positioning System is intended for use with the D…
Corin USA20134
*K130128Trinity Acetabular System
Summary page 3
…mized Positioning System including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty. The Corin Optimized Positioning System is intended for use with the Direct Ant…
Corin Medical2013—
*K130343Corin Trinity Acetabular System with Extra-Long Heads
Summary page 3
…itioning System including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty. The Corin Optimized Positioning System is intended for use with the Direct Anterior or…
Corin USA20132
*K131647Trinity Acetabular System
Summary page 3
…tem including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty. The Corin Optimized Positioning System is intended for use with the Direct Anterior or Posterolater…
Corin USA2013—
*—Corin Instrument 510(k) Exempt (Product Code - KIL)
Named without a submission number
—
†K132788Myspine Pedicle Screw Placement GuidesMedacta International2014—

Also cleared against K111863: 4 other devices →

What descends from it? (8)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195
K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181
K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200

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 35 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
  • 33 of the 146 ancestors have a recall of any class.
  • Of its descendants, K190834 (Corin USA, 2019) has gone furthest, with 5 descendants of its own.
  • 4 other devices also cite its predicate K111863.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · LZO

14in 2025

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
2007high 42 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZO

3,244in 2025

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

What is it indicated for?

The Corin Optimized Positioning System (OPS) is intended to be used as patient-specific surgical instrument to assist in the alignment of components during total hip arthroplasty. The Corin OPS is intended to assist in the orientation of the acetabular cup intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative X-rays and CT imaging scans. The Optimized Positioning System including the Patient Specific…

Read the full statement (117 words)

The Corin Optimized Positioning System (OPS) is intended to be used as patient-specific surgical instrument to assist in the alignment of components during total hip arthroplasty. The Corin OPS is intended to assist in the orientation of the acetabular cup intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative X-rays and CT imaging scans.

The Optimized Positioning System including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty.

The Corin Optimized Positioning System is intended for use with the Direct Anterior or Posterolateral surgical approaches.

The Patient Specific Guides are intended for single use only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K111863

4 other devices cite the same predicate.

  • K162719iTotal® Hip Replacement SystemConformis, Inc. · 20174 recalls
  • K150780Acetabular Cup Orientation SystemMaterialise NV · 2015
  • K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV · 2013
  • K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013

More from Corin USA

70 FDA decisions under this applicant name. See the company

  • K203751OMNIVision systemCorin USA · 2021
  • K202805Optimized Positioning System (OPS) InsightCorin USA · 2020
  • K193545Corin Optimized Positioning System (OPS) FemoralCorin USA · 2020
  • P050016/S012Cormet Hip Resurfacing SystemCorin USA · 2020
  • K193042Optimized Positioning System (OPS) ReViewCorin USA · 2020

Recent decisions in LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K152893 · printed Nov 4, 2026

Cite this page

510(k) Report. “K152893: Corin Optimized Positioning System (OPS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K152893

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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