510(k) · Cleared

Cleared

Responsive Orthopedics Total Hip Arthroplasty System

K163585510(k) TraditionalCleared Jun 2, 2017164-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

Responsive Orthopedics, LLC · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Jun 2, 2017 as substantially equivalent to K001991 (DePuy Orthopaedics, Inc., 2000) and 8 other predicates after a 164-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.

Decided: Jun 2, 2017
Review: 164 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 9

Its longest line of descent runs back 5 generations to K935452 (1994). 94 ancestors in all, the oldest K830313 (1983). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
4 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
3 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
2 generations backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
1 generation backK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
This deviceK163585 Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC · 2017
Descendant · cites it directly · 0 of its ownK183129 Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy · 2019

Most influential descendants

Showing 1 of 1 · See all

K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K935452	P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component	Johnson & Johnson Orthopaedics, Inc.	1994	—
−4	K945518	P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component	Johnson & Johnson Professionals, Inc.	1996	—
−3	K961939	S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)	Johnson & Johnson Professionals, Inc.	1996	—
−2	K974331	Uni-Rom Total Hip System Femoral Stem	Johnson & Johnson Professionals, Inc.	1998	—
−1	K001991	Titan Porocoat Hip Prosthesis	DePuy Orthopaedics, Inc.	2000	—
0 (this device)	K163585	Responsive Orthopedics Total Hip Arthroplasty System	Responsive Orthopedics, LLC	2017	—
+1	K183129	Medtronic Total Hip Arthroplasty System	Medtronic Advanced Energy	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1985	2	0
1986	2	0
1988	1	0
1990	1	0
1991	1	0
1992	3	0
1993	1	0
1994	13	0
1995	8	0
1996	9	0
1997	9	0
1998	3	0
1999	6	0
2000	7	0
2001	4	0
2002	5	0
2003	3	0
2005	3	0
2006	2	0
2007	2	0
2011	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K163585, 1994–2019Source: 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K001991	Titan Porocoat Hip Prosthesis Summary page 4 …s II Product Codes LZO 21 CFR 888.3353 Predicates Depuy Summit Tapered Hip System K001991, S.E. 08/25/2000 Smith&Nephew -- REFLECTION K920430, S.E. 07/21/1992…	DePuy Orthopaedics, Inc.	2000	—
*	K920430	Modular Acetabular Cup System Summary page 4 …Depuy Summit Tapered Hip System K001991, S.E. 08/25/2000 Smith&Nephew -- REFLECTION K920430, S.E. 07/21/1992 K932755, S.E. 05/06/1994 United Orthopedic Corporation –…	Smith & Nephew Richards, Inc.	1992	—
*	K932755	Reflection Acetabular Component Summary page 4 …K001991, S.E. 08/25/2000 Smith&Nephew -- REFLECTION K920430, S.E. 07/21/1992 K932755, S.E. 05/06/1994 United Orthopedic Corporation – U2 Acetabular Components…	Smith & Nephew Richards, Inc.	1994	—
*	K050262	U2 Acetabular Component Summary page 4 …K932755, S.E. 05/06/1994 United Orthopedic Corporation – U2 Acetabular Components K050262, S.E. 08/15/2005 United Orthopedic Corporation – UTF Stem System K11024…	United Orthopedic Corp.	2005	—
*	K110245	United Utf Stem Summary page 4 …Components K050262, S.E. 08/15/2005 United Orthopedic Corporation – UTF Stem System K110245, S.E. 08/04/2011 United Orthopedic Corporation – U2 Femoral Head…	United Orthopedic Corporation	2011	1
*	K111546	U2 Hip System Summary page 5 …ted Orthopedic Corporation – U2 Femoral Head ,1BHFPG K111546, S.E. 07/01/2011 K103479, S.E. 03/10/2011 K022520, S.E. 02/25/2…	United Orthopedic Corp.	2011	1
*	K103479	Novel Tapered Hip Stem Summary page 5 …== ,1BHFPG K111546, S.E. 07/01/2011 K103479, S.E. 03/10/2011 K022520, S.E. 02/25/2003 Ortho Development Co…	Stryker Corp.	2011	—
*	K022520	U2 Acetabular Cup Summary page 5 …1BHFPG K111546, S.E. 07/01/2011 K103479, S.E. 03/10/2011 K022520, S.E. 02/25/2003 Ortho Development Corporation – Ovation™ Hip Stem…	United Orthopedic Corp.	2003	—
*	K062775	European Style Taper,Press-Fit Hip Stem Summary page 5 …K022520, S.E. 02/25/2003 Ortho Development Corporation – Ovation™ Hip Stem K062775, S.E. 01/16/2007 The predicates have not been subject to a design related…	Ortho Development Corp.	2007	4

Also cleared against K001991: 9 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K183129	Medtronic Total Hip Arthroplasty System	Medtronic Advanced Energy	2019	0

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 4 companies; a new generation was cleared every 1.5 years on median.
21 of the 94 ancestors have a recall of any class.
Of its descendants, K183129 (Medtronic Advanced Energy, 2019) has gone furthest, with 0 descendants of its own.
9 other devices also cite its predicate K001991.

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. 2017, 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 Responsive Orthopedics Total Hip Arthroplasty System is indicated for cementless use only in the following cases:

• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

• Rheumatoid arthritis;

• Correction of functional deformity;

• Revision procedures where other treatments or devices have failed; and

• Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Responsive Orthopedics Total Hip Arthroplasty System Acetabular screws are indicated for supplemental fixation of Responsive Orthopedics Acetabular Cup.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K163585 · printed Nov 4, 2026

Cite this page

510(k) Report. “K163585: Responsive Orthopedics Total Hip Arthroplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163585

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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