510(k) · Cleared

Cleared

Pca Alumina Femoral Heads

K063816510(k) TraditionalCleared Feb 2, 200742-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

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

Cleared on Feb 2, 2007 as substantially equivalent to K023901 (Howmedica Osteonics Corp., 2003) and 2 other predicates after a 42-day review. Its family tree reaches back 2 generations to 2000.

Decided: Feb 2, 2007
Review: 42 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K003413 (2000). 4 ancestors in all, the oldest K920831 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK003413 Alumina V40 HeadHowmedica Osteonics Corp. · 2000
1 generation backK023901 Alumina V40 Femoral HeadsHowmedica Osteonics Corp. · 2003
This deviceK063816 Pca Alumina Femoral HeadsStryker Orthopaedics · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K003413	Alumina V40 Head	Howmedica Osteonics Corp.	2000	—
−1	K023901	Alumina V40 Femoral Heads	Howmedica Osteonics Corp.	2003	—
0 (this device)	K063816	Pca Alumina Femoral Heads	Stryker Orthopaedics	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
2000	1	0

FIG. 1 — Lineage of K063816, 2000–2007Source: 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? (3)

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
*	K023901	Alumina V40 Femoral Heads Summary page 2 …cetabular and femoral stem components chosen. Substantial Equivalence: The PCA® Alumina Femoral Heads are substantially equivalent to the Alumina V4OTM Femoral Heads (K023901), cleared by Howmedica Osteonics Corp., PCA Total Hip System - Cementless Use (K92083 1), cleared by Pfizer Hospital Products Gro…	Howmedica Osteonics Corp.	2003	—
*	K920831	Pca Total Hip System (Cementless Use) Summary page 2 …ina Femoral Heads are substantially equivalent to the Alumina V4OTM Femoral Heads (K023901), cleared by Howmedica Osteonics Corp., PCA Total Hip System - Cementless Use (K92083 1), cleared by Pfizer Hospital Products Group, Inc., and the V40TM/C-Taper Adapter Sleeve (K003379), cleared by Howmedica Osteonics…	Pfizer Hospital Products Group, Inc.	1992	—
*	K003379	V-40/C-Taper Adapter Sleeve Summary page 2 …ed by Howmedica Osteonics Corp., PCA Total Hip System - Cementless Use (K92083 1), cleared by Pfizer Hospital Products Group, Inc., and the V40TM/C-Taper Adapter Sleeve (K003379), cleared by Howmedica Osteonics Corp. DEPARTMENT OF HEALTH & HUMAN SERVICES…	Howmedica Osteonics Corp.	2000	—

Also cleared against K023901: 1 other device →

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 7 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
None of the 4 ancestors has a recall.
1 other device also cites its predicate K023901.

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. 2007, 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?

1) noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis (excepting the Osteolock HA Acetabular Cup and Peri-Apatite coated prostheses); 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other…

Read the full statement (114 words)

1) noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

2) rheumatoid arthritis (excepting the Osteolock HA Acetabular Cup and Peri-Apatite coated prostheses);

3) correction of functional deformity;

4) revision procedures where other treatments or devices have failed; and,

5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Peri-Apatite coated prostheses are indicated only for primary uncemented total hip arthroplasty for items 1, 3, & 5 above when offered for sale in the USA.

Femoral head prostheses are indicated for use in cemented and cementless total hip arthroplasty, depending upon the indications of the acetabular and femoral stem components chosen.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063816 · printed Nov 5, 2026

Cite this page

510(k) Report. “K063816: Pca Alumina Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063816

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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