510(k) · Cleared

Cleared

Multifit Total Hip System

K101472510(k) AbbreviatedCleared Jan 5, 2011223-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

Otis Biotech Co., Ltd. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Jan 5, 2011 as substantially equivalent to K011489 (DePuy Orthopaedics, Inc., 2001) and 9 other predicates after a 223-day review. Its family tree reaches back 6 generations to 1994.

Decided: Jan 5, 2011
Review: 223 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 10

Its longest line of descent runs back 6 generations to K935452 (1994). 37 ancestors in all, the oldest K812672 (1981). No later device cites it as a predicate yet.

By dateBy generation

Root · 6 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
5 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
4 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
3 generations backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
2 generations backK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
1 generation backK011489 Summit Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
This deviceK101472 Multifit Total Hip SystemOtis Biotech Co., Ltd. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K935452	P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component	Johnson & Johnson Orthopaedics, Inc.	1994	—
−5	K945518	P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component	Johnson & Johnson Professionals, Inc.	1996	—
−4	K961939	S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)	Johnson & Johnson Professionals, Inc.	1996	—
−3	K974331	Uni-Rom Total Hip System Femoral Stem	Johnson & Johnson Professionals, Inc.	1998	—
−2	K001991	Titan Porocoat Hip Prosthesis	DePuy Orthopaedics, Inc.	2000	—
−1	K011489	Summit Duofix Hip Prosthesis	DePuy Orthopaedics, Inc.	2001	—
0 (this device)	K101472	Multifit Total Hip System	Otis Biotech Co., Ltd.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1983	1	0
1984	1	0
1985	1	0
1991	2	0
1992	2	0
1993	1	0
1994	5	0
1995	1	0
1996	3	0
1997	3	0
1998	3	0
1999	2	0
2000	2	0
2002	1	0
2005	1	0

FIG. 1 — Lineage of K101472, 1994–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K011489	Summit Duofix Hip Prosthesis Summary page 2 …Code Number Cementless Tapered Stem i )Depuy Orthopaedicss, Inc. K01 1489 LPH SummitT~M DuoFixim Hip Prosthesis ii Osteonic…	DePuy Orthopaedics, Inc.	2001	—
*	K982032	Osteonics Omnifit HA Hip Stem Series, Osteonics Secur-Fit HA Hip Stem Series, Osteonics… Summary page 2 …01 1489 LPH SummitT~M DuoFixim Hip Prosthesis ii Osteonics corporation. K982032 MEH Osteonics Imnifit HA Hip stem series Cement Collared Stem i )Wr…	Osteonics Corp.	1998	1
*	K972641	Dual Offset Perfecta Imc Hip Stem Summary page 2 …2032 MEH Osteonics Imnifit HA Hip stem series Cement Collared Stem i )Wright Medical Technology INC. K972641 JDI PERFECTAO IMC Hip System ii) Smith & Nephew,…	Wrightmedicaltechnologyinc	1997	—
*	K990369	Synergy Cemented Hip Stem Summary page 2 …K972641 JDI PERFECTAO IMC Hip System ii) Smith & Nephew, Inc. K990369 LPH Synergy Cemented Hip stem Acetabular System i )Zimmer, Inc.…	Smith & Nephew, Inc.	1999	—
*	K934765	Trilogy Acetabular System Summary page 2 …K990369 LPH Synergy Cemented Hip stem Acetabular System i )Zimmer, Inc. K934765 LPH Trilogy Acetahular System i i Smith & Nephew,…	Zimmer, Inc.	1994	16
*	K002747	Reflection Cross-Linked Uhmwpe Acetabular Components Summary page 2 …K934765 LPH Trilogy Acetahular System i i Smith & Nephew, Inc. K002747 LPH, Reflection Cross-lintked UHMWPE D…	Smith & Nephew, Inc.	2000	—
*	K812672	Self-Centering Hip Summary page 2 …HMWPE D acetabular component Bipolar System i )Depuy, Inc. K812672 KWY Self-centering Hip prosthesis ii) Biomet, Inc…	Depuy, Inc.	1981	—
*	K051569	Ringloc BI-Polar Acetabular Component Summary page 2 …K812672 KWY Self-centering Hip prosthesis ii) Biomet, Inc. K051569 JED Ringloc Si-polar acetabular component…	Biomet, Inc.	2005	4
*	K021673	Total Hip Femoral Head - 12/14 Taper Summary page 2 …Ringloc Si-polar acetabular component Femoral Ball Head i ) Smith & Nephew, Inc. K02 1673 LZO Total Hip Femoral Head - 12/14 Taper…	Smith & Nephew, Inc.	2002	1
*	K911684	Biomet Cobalt-Chrome Femoral Components Summary page 2 …Total Hip Femoral Head - 12/14 Taper ii) Biomet, Inc. K91 1684 JDI Biomet Cobalt-chrome femoral components…	Biomet, Inc.	1991	12

Also cleared against K011489: 4 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 17 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
8 of the 36 ancestors have a recall of any class.
4 other devices also cite its predicate K011489.

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. 2011, this device’s year, is highlighted.

FDA decisions per year · LZO

14in 2025

2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	9	87	2	138
2008	11	63	13	125
2009	7	83	42	189
2010	15	78	0	394
2011	13	87	10	544
2012	14	98	14	963
2013	26	100	0	1,370
2014	13	85	1	1,477
2015	12	115	1	1,348
2016	10	177	9	1,728
2017	16	257	5	2,165
2018	18	163	2	3,133
2019	28	109	4	3,066
2020	18	112	3	1,963
2021	12	170	0	2,199
2022	11	279	4	1,985
2023	10	122	2	2,066
2024	11	111	1	2,586
2025	14	119	1	3,244
2026	9	102	0	—

What is it indicated for?

The hip system is intended to be cemented stem or un cemented stem use.

The MultiFit Total Hip System is to replace a defective hip joint in the following cases:

1) 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;

2) Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis;

3) Patients suffering from disability due to previous fusion and previously failed endo-prostheses;

4) Patients with acute femoral neck fractures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101472 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101472: Multifit Total Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101472

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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