510(k) Report

510(k) · Cleared

Cleared

CoreHip® System

K172235510(k) TraditionalCleared Mar 28, 2018246-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

Aesculap Implants Systems, LLC · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Mar 28, 2018 as substantially equivalent to K150062 (Aesculap Implant Systems, LLC, 2015) and 11 other predicates after a 246-day review. Its family tree reaches back 11 generations to 1996.

Decided
Mar 28, 2018
Review
246 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
12

Its longest line of descent runs back 11 generations to K955033 (1996). 128 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 1 other ancestor2008: 5 other ancestors2006: 5 other ancestors2005: 5 other ancestors2007: 2 other ancestors2003: 7 other ancestors2002: 8 other ancestors2001: 4 other ancestors2000: 9 other ancestors1999: 2 other ancestors1997: 9 other ancestors2004: 2 other ancestors1998: 6 other ancestors1996: 7 other ancestors1995: 12 other ancestors1994: 15 other ancestors1993: 3 other ancestors1992: 3 other ancestors1991: 4 other ancestors1990: 2 other ancestors1987: 2 other ancestors1984: 1 other ancestor1981: 1 other ancestor1985: 1 other ancestorReference device: K071723 · Zimmer Porolock Mis Stem · Zimmer GmbH · 2008 · recalledK955033 · Rim Flare Acetabular Component · Intermedics Orthopedics · 1996K983509 · Inter-OP Acetabular System - Durasul Acetabular Insert · Sulzer Orthopedics, Inc. · 1999K993259 · Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads · Sulzer Orthopedics, Inc. · 2000 · recalledK022902 · Smith & Nephew Hip System · Smith & Nephew, Inc. · 2002×2: 2 generations cleared close together, K040191 (2004), K043079 (2004) ×2: 2 generations cleared close together, K060437 (2006), K061344 (2006) K092143 · Excia Total Hip System M an ML Femoral Stem · Aesculap Implant Systems, Inc. · 2009K140915 · Excia Total Hip System · Aesculap Implant Systems, LLC · 2014K150062 · Excia Total Hip System · Aesculap Implant Systems, LLC · 201519801990200020102020
Other ancestors, by generation 1 generation back: 7 other ancestors2 generations back: 16 other ancestors3 generations back: 30 other ancestors4 generations back: 28 other ancestors5 generations back: 26 other ancestors6 generations back: 4 other ancestors7 generations back: 5 other ancestors K150062 · Excia Total Hip System · Aesculap Implant Systems, LLC · 2015K140915 · Excia Total Hip System · Aesculap Implant Systems, LLC · 2014K092143 · Excia Total Hip System M an ML Femoral Stem · Aesculap Implant Systems, Inc. · 2009K061344 · Excia Total Hip System Lateral Offset · Aesculap, Inc. · 2006K060437 · Excia Total Hip System with U-Cap · Aesculap, Inc. · 2006K043079 · Bicontact Hip System with U-Cap · Aesculap · 2004K040191 · Bicontact Hip Stem and Femoral Head · Aesculap · 2004K022902 · Smith & Nephew Hip System · Smith & Nephew, Inc. · 2002K993259 · Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads · Sulzer Orthopedics, Inc. · 2000 · recalledK983509 · Inter-OP Acetabular System - Durasul Acetabular Insert · Sulzer Orthopedics, Inc. · 1999K955033 · Rim Flare Acetabular Component · Intermedics Orthopedics · 1996−10−50
  1. Root · 11 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
  2. 7 generations between
  3. 3 generations backK092143 Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc. · 2009
  4. 2 generations backK140915 Excia Total Hip SystemAesculap Implant Systems, LLC · 2014
  5. 1 generation backK150062 Excia Total Hip SystemAesculap Implant Systems, LLC · 2015
  6. This deviceK172235 CoreHip® SystemAesculap Implants Systems, LLC · 2018
Show all 11 generations
  1. Root · 11 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
  2. 10 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
  3. 9 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
  4. 8 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
  5. 7 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
  6. 6 generations backK043079 Bicontact Hip System with U-CapAesculap · 2004
  7. 5 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
  8. 4 generations backK061344 Excia Total Hip System Lateral OffsetAesculap, Inc. · 2006
  9. 3 generations backK092143 Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc. · 2009
  10. 2 generations backK140915 Excia Total Hip SystemAesculap Implant Systems, LLC · 2014
  11. 1 generation backK150062 Excia Total Hip SystemAesculap Implant Systems, LLC · 2015
  12. This deviceK172235 CoreHip® SystemAesculap Implants Systems, LLC · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K955033Rim Flare Acetabular ComponentIntermedics Orthopedics1996—
−10K983509Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc.1999—
−9K993259Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc.20003
−8K022902Smith & Nephew Hip SystemSmith & Nephew, Inc.2002—
−7K040191Bicontact Hip Stem and Femoral HeadAesculap2004—
−6K043079Bicontact Hip System with U-CapAesculap2004—
−5K060437Excia Total Hip System with U-CapAesculap, Inc.2006—
−4K061344Excia Total Hip System Lateral OffsetAesculap, Inc.2006—
−3K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.2009—
−2K140915Excia Total Hip SystemAesculap Implant Systems, LLC2014—
−1K150062Excia Total Hip SystemAesculap Implant Systems, LLC2015—
0 (this device)K172235CoreHip® SystemAesculap Implants Systems, LLC2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198410
198510
198720
199020
199140
199230
199330
1994150
1995120
199670
199790
199860
199920
200090
200140
200280
200370
200420
200550
200650
200720
200850
200910
FIG. 1 — Lineage of K172235, 1996–2018Source: 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? (12)

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
*K150062Excia Total Hip System
Summary page 4
…STANTIAL EQUIVALENCE Aesculap Implant Systems, LLC (AIS) believes that CoreHip® System is substantially equivalent to the Primary Predicate AIS Excia® Total Hip System (K150062 (including K140915, K092143, K090299, K081973, K082991, K062684, K061699, K061344, K060918, K060437, and K042344)) and Reference…
Aesculap Implant Systems, LLC2015—
*K140915Excia Total Hip System
Summary page 4
…E Aesculap Implant Systems, LLC (AIS) believes that CoreHip® System is substantially equivalent to the Primary Predicate AIS Excia® Total Hip System (K150062 (including K140915, K092143, K090299, K081973, K082991, K062684, K061699, K061344, K060918, K060437, and K042344)) and Reference Predicate Zimmer Fi…
Aesculap Implant Systems, LLC2014—
*K092143Excia Total Hip System M an ML Femoral Stem
Summary page 4
…ap Implant Systems, LLC (AIS) believes that CoreHip® System is substantially equivalent to the Primary Predicate AIS Excia® Total Hip System (K150062 (including K140915, K092143, K090299, K081973, K082991, K062684, K061699, K061344, K060918, K060437, and K042344)) and Reference Predicate Zimmer Fitmore Kne…
Aesculap Implant Systems, Inc.2009—
*K090299Biolox Option Ceramic Femoral Head and Metha XL Heads
Summary page 4
…t Systems, LLC (AIS) believes that CoreHip® System is substantially equivalent to the Primary Predicate AIS Excia® Total Hip System (K150062 (including K140915, K092143, K090299, K081973, K082991, K062684, K061699, K061344, K060918, K060437, and K042344)) and Reference Predicate Zimmer Fitmore Knee System…
Aesculap Implant Systems2009—
*K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip System
Summary page 4
…, LLC (AIS) believes that CoreHip® System is substantially equivalent to the Primary Predicate AIS Excia® Total Hip System (K150062 (including K140915, K092143, K090299, K081973, K082991, K062684, K061699, K061344, K060918, K060437, and K042344)) and Reference Predicate Zimmer Fitmore Knee System (Porolock…
Aesculap Implant Systems, Inc.2008—
*K082991Biolox Delta Ceramic Femoral Head
Summary page 4
…S) believes that CoreHip® System is substantially equivalent to the Primary Predicate AIS Excia® Total Hip System (K150062 (including K140915, K092143, K090299, K081973, K082991, K062684, K061699, K061344, K060918, K060437, and K042344)) and Reference Predicate Zimmer Fitmore Knee System (Porolock MIS Stem…
Aesculap Implant Systems, Inc.2008—
*K062684Excia Total Hip System 36MM Ceramic Head
Summary page 4
…es that CoreHip® System is substantially equivalent to the Primary Predicate AIS Excia® Total Hip System (K150062 (including K140915, K092143, K090299, K081973, K082991, K062684, K061699, K061344, K060918, K060437, and K042344)) and Reference Predicate Zimmer Fitmore Knee System (Porolock MIS Stem) (K07172…
Aesculap, Inc.2006—
*K061699EXCIA
Summary page 4
…oreHip® System is substantially equivalent to the Primary Predicate AIS Excia® Total Hip System (K150062 (including K140915, K092143, K090299, K081973, K082991, K062684, K061699, K061344, K060918, K060437, and K042344)) and Reference Predicate Zimmer Fitmore Knee System (Porolock MIS Stem) (K071723). DEVI…
Aesculap, Inc.2006—
*K061344Excia Total Hip System Lateral Offset
Summary page 4
…ystem is substantially equivalent to the Primary Predicate AIS Excia® Total Hip System (K150062 (including K140915, K092143, K090299, K081973, K082991, K062684, K061699, K061344, K060918, K060437, and K042344)) and Reference Predicate Zimmer Fitmore Knee System (Porolock MIS Stem) (K071723). DEVICE DESCRI…
Aesculap, Inc.2006—
*K060918Excia Total Hip System 12/14 Trunnion with Ceramic Head
Summary page 4
…substantially equivalent to the Primary Predicate AIS Excia® Total Hip System (K150062 (including K140915, K092143, K090299, K081973, K082991, K062684, K061699, K061344, K060918, K060437, and K042344)) and Reference Predicate Zimmer Fitmore Knee System (Porolock MIS Stem) (K071723). DEVICE DESCRIPTION The…
Aesculap, Inc.2006—
*K060437Excia Total Hip System with U-Cap
Summary page 4
…ally equivalent to the Primary Predicate AIS Excia® Total Hip System (K150062 (including K140915, K092143, K090299, K081973, K082991, K062684, K061699, K061344, K060918, K060437, and K042344)) and Reference Predicate Zimmer Fitmore Knee System (Porolock MIS Stem) (K071723). DEVICE DESCRIPTION The CoreHip…
Aesculap, Inc.2006—
*K042344Excia Total Hip System
Summary page 4
…nt to the Primary Predicate AIS Excia® Total Hip System (K150062 (including K140915, K092143, K090299, K081973, K082991, K062684, K061699, K061344, K060918, K060437, and K042344)) and Reference Predicate Zimmer Fitmore Knee System (Porolock MIS Stem) (K071723). DEVICE DESCRIPTION The CoreHip System includ…
Aesculap, Inc.200510
†K071723Zimmer Porolock Mis StemZimmer GmbH20082

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 22 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
  • 31 of the 127 ancestors have a recall of any class.

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. 2018, 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 CoreHip® System is intended to replace a hip joint. The device is intended for: • Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur • Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis • Patients suffering from…

Read the full statement (120 words)

The CoreHip® System is intended to replace a hip joint. The device is intended for:

• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur

• Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis

• Patients suffering from disability due to previous fusion

• Patients with acute femoral neck fractures

The CoreHip® System is available with two (2) types of femoral stem fixation. One stem is manufactured from CoCrMo and is intended for cemented fixation and the other femoral stem is manufactured from Ti with Plasmapore® and is intended for uncemented (pressfit) fixation.

Indications for use as stated in the FDA summary.

More from Aesculap Implants Systems, LLC

3 FDA decisions under this applicant name. See the company

  • K231769activL® Next Generation InstrumentationAesculap Implants Systems, LLC · 2023
  • K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015

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/K172235 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172235: CoreHip® System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172235

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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