510(k) · Cleared

Cleared

Preserve Hip Stem

K112080510(k) SpecialCleared Dec 28, 2011160-day reviewClass III21 CFR 888.3330

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

Wrightmedicaltechnologyinc · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Cleared on Dec 28, 2011 as substantially equivalent to K100866 (Wrightmedicaltechnologyinc, 2010) and 4 other predicates after a 160-day review. Its family tree reaches back 2 generations to 1989. 2 of the 16 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.

Decided: Dec 28, 2011
Review: 160 days
Class: Class III
Product code: KWA
Recalls: None
Predicates: 5

Its longest line of descent runs back 2 generations to K893685 (1989). 7 ancestors in all. 8 later devices descend from it, 5 citing it directly. 2 of the 16 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK893685 Ceramic Femoral HeadDow Corning Wright · 1989
1 generation backK100866 Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · Recalled (Class I)
This deviceK112080 Preserve Hip StemWrightmedicaltechnologyinc · 2011
Descendant · cites it directly · 4 of its ownK150302 PROFEMUR Preserve Classic StemMicroport Orthopedics, Inc. · 2015
Descendant · cites it directly · 3 of its ownK150133 PROFEMUR Preserve Size 1-3 Hip StemsMicroport Orthopedics, Inc. · 2015
Descendant · cites it directly · 3 of its ownK121221 Profemur Z Revision Hip StemWrightmedicaltechnologyinc · 2012
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 ownK250444 NEXUS® Hip StemMicroport Orthopedics, Inc. · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2012high 2 (2012) · low 0 (2013)2026

Class I recalls in this family

K100866 Profemur Hip System Modular Necksdirect predicate · 2010
K091423 Profemur Hip System Modular Necksdirect predicate · 2009

Most influential descendants

Showing 5 of 8 · See all

K150302PROFEMUR Preserve Classic StemMicroport Orthopedics, Inc. · 2015 · cites it directly4descendants
K150133PROFEMUR Preserve Size 1-3 Hip StemsMicroport Orthopedics, Inc. · 2015 · cites it directly3descendants
K121221Profemur Z Revision Hip StemWrightmedicaltechnologyinc · 2012 · cites it directly3descendants
K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018 · cites it directly1descendant
K250444NEXUS® Hip StemMicroport Orthopedics, Inc. · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K893685	Ceramic Femoral Head	Dow Corning Wright	1989	—
−1	K100866	Profemur Hip System Modular Necks	Wrightmedicaltechnologyinc	2010	Class I
0 (this device)	K112080	Preserve Hip Stem	Wrightmedicaltechnologyinc	2011	—
+1	K150302	PROFEMUR Preserve Classic Stem	Microport Orthopedics, Inc.	2015	—
+1	K150133	PROFEMUR Preserve Size 1-3 Hip Stems	Microport Orthopedics, Inc.	2015	—
+1	K121221	Profemur Z Revision Hip Stem	Wrightmedicaltechnologyinc	2012	—
+1	K173898	MicroPort Orthopedics Total Hip Systems MR Labeling	Microport Orthopedics Inc. (Mpo)	2018	—
+2	K250444	NEXUS® Hip Stem	Microport Orthopedics, Inc.	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2006	1	0
2008	1	0
2009	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	2	0
2015	2	0
2018	1	0
2022	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K112080, 1989–2025Source: 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.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (5)

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
*	K100866	Profemur Hip System Modular Necks Summary page 1 …PROFEMURS Z (STEM) PRO-FEMURO Hip System 510(k): K100866, K091423, K060358, K021346, K012091 Predicate Classification and Number:…	Wrightmedicaltechnologyinc	2010	Class I
*	K091423	Profemur Hip System Modular Necks Summary page 1 …PROFEMURS Z (STEM) PRO-FEMURO Hip System 510(k): K100866, K091423, K060358, K021346, K012091 Predicate Classification and Number:…	Wrightmedicaltechnologyinc	2009	Class I
*	K060358	Profemur TL Hip Stem Summary page 1 …MURS Z (STEM) PRO-FEMURO Hip System 510(k): K100866, K091423, K060358, K021346, K012091 Predicate Classification and Number: Or…	Wrightmedicaltechnologyinc	2006	—
*	K021346	Stem Hip Replacement System, Model PHA002XX Summary page 1 …TEM) PRO-FEMURO Hip System 510(k): K100866, K091423, K060358, K021346, K012091 Predicate Classification and Number: Orthopedics…	Wrightmedicaltechnologyinc	2002	3
*	K012091	Pro-Femur Summary page 1 …FEMURO Hip System 510(k): K100866, K091423, K060358, K021346, K012091 Predicate Classification and Number: Orthopedics/87/ KWA, 888.3330 DEVICE INFORMATION A. Device Description…	Wrightmedicaltechnologyinc	2001	1

Also cleared against K100866: 3 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K150302	PROFEMUR Preserve Classic Stem	Microport Orthopedics, Inc.	2015	4
K150133	PROFEMUR Preserve Size 1-3 Hip Stems	Microport Orthopedics, Inc.	2015	3
K121221	Profemur Z Revision Hip Stem	Wrightmedicaltechnologyinc	2012	3
K173898	MicroPort Orthopedics Total Hip Systems MR Labeling	Microport Orthopedics Inc. (Mpo)	2018	1
K122778	Profemur Z Revision Hip Stem	Wrightmedicaltechnologyinc	2012	0

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K100866Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · Direct predicate · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 20.6 years on median.
4 of the 7 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K150302 (Microport Orthopedics, Inc., 2015) has gone furthest, with 4 descendants of its own.
3 other devices also cite its predicate K100866.

How does its category compare?

All KWA devices

KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · KWA

4in 2012

2007high 11 (2011) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWA

76in 2012

2007high 167 (2010) · low 57 (2008)2026

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

Recalls per year · KWA

19in 2023

2007high 84 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KWA

1,216in 2025

2007high 24,601 (2012) · low 213 (2007)2025

MAUDE reports naming product code KWA, 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	8	74	0	213
2008	9	57	13	762
2009	7	139	0	820
2010	6	167	84	3,348
2011	11	101	28	17,737
2012	4	76	21	24,601
2013	0	—	1	20,020
2014	0	—	0	16,494
2015	0	—	0	12,339
2016	0	—	1	7,872
2017	0	—	1	6,847
2018	0	—	1	6,388
2019	0	—	2	7,628
2020	0	—	1	4,538
2021	0	—	0	2,064
2022	0	—	0	1,617
2023	0	—	19	1,474
2024	0	—	0	1,168
2025	0	—	0	1,216
2026	0	—	0	—

What is it indicated for?

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 Preserve hip stem is intended for cementless hip arthroplasty.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112080 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112080: Preserve Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112080

Report an extraction error

Are you the manufacturer?

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