510(k) Report

510(k) · Cleared

Cleared

MALUC™ Total Hip Arthroplasty System

K162125510(k) TraditionalCleared May 10, 2017282-day reviewClass II21 CFR 888.3350

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

Surgtech, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on May 10, 2017 as substantially equivalent to K023453 (DePuy Orthopaedics, Inc., 2002) and 8 other predicates after a 282-day review. Its family tree reaches back 6 generations to 1994.

Decided
May 10, 2017
Review
282 days
Class
Class II
Product code
JDI
Recalls
None
Predicates
9

Its longest line of descent runs back 6 generations to K941141 (1994). 49 ancestors in all, the oldest K900638 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor2003: 1 other ancestor2002: 2 other ancestors2001: 5 other ancestors2000: 2 other ancestors1999: 2 other ancestors1998: 4 other ancestors1997: 3 other ancestors1995: 10 other ancestors1994: 6 other ancestors1991: 1 other ancestor1996: 3 other ancestors1993: 1 other ancestor1990: 2 other ancestorsK941141 · Precision Ostelock SP Femoral Component · Howmedica Corp. · 1994K972228 · Meridian Titanium Femoral Stems · Howmedica, Inc. · 1997K993768 · Citation TMZF HA Stem · Howmedica Osteonics Corp. · 2000 · recalledK001448 · Trident Acetabular Shells: PS-HA · Howmedica Osteonics Corp. · 2000K013676 · Trident Hemispherical Acetabular Shells · Howmedica Osteonics Corp. · 2001 · recalledK040412 · Trident T Acetabular Shells · Stryker Orthopaedics · 2004199019952000200520102015
Other ancestors, by generation 1 generation back: 8 other ancestors2 generations back: 11 other ancestors3 generations back: 12 other ancestors4 generations back: 3 other ancestors5 generations back: 8 other ancestors6 generations back: 1 other ancestor K040412 · Trident T Acetabular Shells · Stryker Orthopaedics · 2004K013676 · Trident Hemispherical Acetabular Shells · Howmedica Osteonics Corp. · 2001 · recalledK001448 · Trident Acetabular Shells: PS-HA · Howmedica Osteonics Corp. · 2000K993768 · Citation TMZF HA Stem · Howmedica Osteonics Corp. · 2000 · recalledK972228 · Meridian Titanium Femoral Stems · Howmedica, Inc. · 1997K941141 · Precision Ostelock SP Femoral Component · Howmedica Corp. · 1994−50
  1. Root · 6 generations backK941141 Precision Ostelock SP Femoral ComponentHowmedica Corp. · 1994
  2. 5 generations backK972228 Meridian Titanium Femoral StemsHowmedica, Inc. · 1997
  3. 4 generations backK993768 Citation TMZF HA StemHowmedica Osteonics Corp. · 2000 · Recalled
  4. 3 generations backK001448 Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000
  5. 2 generations backK013676 Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. · 2001 · Recalled
  6. 1 generation backK040412 Trident T Acetabular ShellsStryker Orthopaedics · 2004
  7. This deviceK162125 MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc. · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K941141Precision Ostelock SP Femoral ComponentHowmedica Corp.1994—
−5K972228Meridian Titanium Femoral StemsHowmedica, Inc.1997—
−4K993768Citation TMZF HA StemHowmedica Osteonics Corp.200012
−3K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp.2000—
−2K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp.20018
−1K040412Trident T Acetabular ShellsStryker Orthopaedics2004—
0 (this device)K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199020
199110
199310
199460
1995100
199630
199730
199840
199920
200020
200150
200220
200310
200710
FIG. 1 — Lineage of K162125, 1994–2017Source: 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 JDI? 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 JDI device

  1. #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 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? (9)

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
*K023453Depuy Summit FX Cemented Hip Prosthesis
Summary page 4
…: JDI, LPH, LZO (a)(3) Predicate Devices: Primary: DePuy SUMMIT (K023453); Additional: Stryker Exeter V40 (K011623);…
DePuy Orthopaedics, Inc.2002—
*K011623Exeter Hip System with V40 Taper
Summary page 4
…Primary: DePuy SUMMIT (K023453); Additional: Stryker Exeter V40 (K011623); Stryker Accolade TMZF (K032300);…
Howmedica Osteonics Corp.2001—
*K032300Accolade-J Hip Stem Series
Summary page 4
…al: Stryker Exeter V40 (K011623); Stryker Accolade TMZF (K032300); Stryker Trident (K040412, K991952,…
Howmedica Osteonics Corp.20031
*K040412Trident T Acetabular Shells
Summary page 4
…Stryker Accolade TMZF (K032300); Stryker Trident (K040412, K991952, K022077, K010757, K070885);…
Stryker Orthopaedics2004—
*K991952Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts
Summary page 4
…Stryker Accolade TMZF (K032300); Stryker Trident (K040412, K991952, K022077, K010757, K070885);…
Howmedica Osteonics Corp.1999—
*K02207736MM V40 Femoral Head Components (Lfit and Non-Lfit)
Summary page 4
…Stryker Trident (K040412, K991952, K022077, K010757, K070885); Depuy PINNACLE with GVF Liner (K000306);…
Howmedica Osteonics Corp.200212
*K010757Lfit V40 Femoral Head Components
Summary page 4
…Stryker Trident (K040412, K991952, K022077, K010757, K070885); Depuy PINNACLE with GVF Liner (K000306); (a)(4)…
Howmedica Osteonics Corp.20014
*K070885Universal Taper Delta Femoral Head
Summary page 4
…Stryker Trident (K040412, K991952, K022077, K010757, K070885); Depuy PINNACLE with GVF Liner (K000306); (a)(4) Device De…
Howmedica Osteonics Corp.2007—
*K000306Pinnacle Acetabular System
Summary page 4
…K022077, K010757, K070885); Depuy PINNACLE with GVF Liner (K000306); (a)(4) Device Description: The MALUC™ Total Hip Arthroplasty System (THA) system is used for primary total hip repl…
DePuy Orthopaedics, Inc.20001

Also cleared against K023453: 2 other devices →

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 23 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
  • 15 of the 49 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K023453.

How does its category compare?

All JDI devices

JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · JDI

1in 2025

2007: 32008: 52009: 32011: 22012: 42013: 32014: 32015: 32016: 42017: 12018: 12019: 22020: 72021: 32022: 32023: 22024: 32025: 12026 (partial year): 2
2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007: 81 days median2008: 96 days median2009: 65 days median2012: 167 days median2013: 176 days median2014: 98 days median2015: 190 days median2016: 166 days median2020: 247 days median2021: 162 days median2022: 69 days median2024: 59 days median
2007high 247 (2020) · low 59 (2024)2026

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

Recalls per year · JDI

1in 2025

2007: 262008: 62009: 32010: 32011: 52012: 42013: 112014: 32015: 12016: 52017: 52018: 12019: 12020: 772025: 1
2007high 77 (2020) · low 0 (2021)2026

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

Adverse event reports per year · JDI

1,644in 2025

2007: 6962008: 8102009: 9642010: 2,0402011: 3,1602012: 5,1222013: 5,2062014: 4,9682015: 4,9062016: 3,9952017: 6,1352018: 6,7282019: 7,4072020: 4,0152021: 3,1702022: 1,9782023: 1,6352024: 1,8212025: 1,644
2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, 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
200738126696
20085966810
20093653964
20100—32,040
20112—53,160
2012416745,122
20133176115,206
201439834,968
2015319014,906
2016416653,995
20171—56,135
20181—16,728
20192—17,407
20207247774,015
2021316203,170
202236901,978
20232—01,635
202435901,821
20251—11,644
20262—0—

What is it indicated for?

The SurgTech MALUC™ System is intended for use for cases of severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery (including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty and/or total arthroplasty), and certain cases of ankylosis.

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 K023453

2 other devices cite the same predicate.

  • K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional…Depuy Ireland UC · 2024
  • K170339Summit Hip SystemDePuy Orthopaedics, Inc. · 2018

More from Surgtech, Inc.

6 FDA decisions under this applicant name. See the company

  • K191192SurgTech GENOLL Total Knee SystemSurgtech, Inc. · 2019
  • K173455SurgTech Bipolar Head SystemSurgtech, Inc. · 2018
  • K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc. · 2017
  • K161894SurgTech Trauma SystemSurgtech, Inc. · 2017
  • K152200SurgTech Interbody SystemSurgtech, Inc. · 2016

Recent decisions in JDI

The JDI category page

  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026
  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet · 2025
  • K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip…Smith & Nephew, Inc. · 2024
  • K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024

https://510kreport.com/device/K162125 · printed Nov 5, 2026

Cite this page

510(k) Report. “K162125: MALUC™ Total Hip Arthroplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162125

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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