510(k) · Cleared

Cleared

Profemur Renaissance Classic Hip Stem

K130984510(k) SpecialCleared May 24, 201345-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

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

Cleared on May 24, 2013 as substantially equivalent to K051995 (Wrightmedicaltechnologyinc, 2005) after a 45-day review. Its family tree reaches back 1 generation to 2005. 4 later devices descend from it.

Decided: May 24, 2013
Review: 45 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K051995 (2005). 4 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK051995 Profemur Renaissance Hip StemWrightmedicaltechnologyinc · 2005
This deviceK130984 Profemur Renaissance Classic Hip StemWrightmedicaltechnologyinc · 2013
Descendant · cites it directly · 3 of its ownK141235 Profemur Renaissance Classic Long Neck Hip StemsMicroport Orthopedics, Inc. · 2014
Descendant · cites it directly · 1 of its ownK173898 MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018
Descendant · 2 generations on · 0 of its ownK240452 Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024
Descendant · 2 generations on · 0 of its ownK213816 MPO Hip InstrumentsMicroport Orthopedics, Inc. · 2022

Most influential descendants

Showing 4 of 4 · See all

K141235Profemur Renaissance Classic Long Neck Hip StemsMicroport Orthopedics, Inc. · 2014 · cites it directly3descendants
K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018 · cites it directly1descendant
K240452Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024 · 2 generations on0descendants
K213816MPO Hip InstrumentsMicroport Orthopedics, Inc. · 2022 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K051995	Profemur Renaissance Hip Stem	Wrightmedicaltechnologyinc	2005	—
0 (this device)	K130984	Profemur Renaissance Classic Hip Stem	Wrightmedicaltechnologyinc	2013	—
+1	K141235	Profemur Renaissance Classic Long Neck Hip Stems	Microport Orthopedics, Inc.	2014	—
+1	K173898	MicroPort Orthopedics Total Hip Systems MR Labeling	Microport Orthopedics Inc. (Mpo)	2018	—
+2	K240452	Ceramic Femoral Head	Microport Orthopedics, Inc.	2024	—
+2	K213816	MPO Hip Instruments	Microport Orthopedics, Inc.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2018	1	0
2022	1	0
2024	1	0

FIG. 1 — Lineage of K130984, 2005–2024Source: 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? (1)

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
*	K051995	Profemur Renaissance Hip Stem Summary page 1 …evices: PROFEMUR® RENAISSANCE®& Hip Stem, K05 1995 Headquarters Tab 007: Page I of 3 Wr…	Wrightmedicaltechnologyinc	2005	—
†	K123688	Profemur TL Classic Hip Stem	Wrightmedicaltechnologyinc	2013	—
†	K100866	Profemur Hip System Modular Necks	Wrightmedicaltechnologyinc	2010	Class I
†	K091423	Profemur Hip System Modular Necks	Wrightmedicaltechnologyinc	2009	Class I
†	K123434	Profemur Z Classic Stems	Wrightmedicaltechnologyinc	2013	1
†	K121221	Profemur Z Revision Hip Stem	Wrightmedicaltechnologyinc	2012	—
†	K122382	Dynasty Biofoam Shell	Wrightmedicaltechnologyinc	2012	—
†	K122218	Advance Total Knee System-Patella	Wrightmedicaltechnologyinc	2013	—

Also cleared against K051995: 2 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K141235	Profemur Renaissance Classic Long Neck Hip Stems	Microport Orthopedics, Inc.	2014	3
K173898	MicroPort Orthopedics Total Hip Systems MR Labeling	Microport Orthopedics Inc. (Mpo)	2018	1

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?

Its one ancestor has no recall.
Of its descendants, K141235 (Microport Orthopedics, Inc., 2014) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K051995.

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. 2013, 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 PROFEMUR® RENAISSANCE® Classic Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of…

Read the full statement (101 words)

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

The PROFEMUR® RENAISSANCE® Classic Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130984 · printed Nov 5, 2026

Cite this page

510(k) Report. “K130984: Profemur Renaissance Classic Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130984

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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