510(k) · Cleared

Cleared

Novel Tapered Hip Stem

K103479510(k) TraditionalCleared Mar 10, 2011104-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 Corp. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Cleared on Mar 10, 2011 as substantially equivalent to K994366 (Howmedica Osteonics Corp., 2000) and 3 other predicates after a 104-day review. Its family tree reaches back 4 generations to 1994. 53 later devices descend from it.

Decided: Mar 10, 2011
Review: 104 days
Class: Class II
Product code: MEH
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K921308 (1994). 18 ancestors in all, the oldest K921301 (1994). 53 later devices descend from it, 10 citing it directly.

By dateBy generation

Root · 4 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
3 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
2 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
1 generation backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
This deviceK103479 Novel Tapered Hip StemStryker Corp. · 2011
Descendant · cites it directly · 46 of its ownK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
Descendant · cites it directly · 30 of its ownK123604 Abg Iii Monolithic Hip StemHowmedica Osteonics Corp. · 2013 · Recalled
Descendant · cites it directly · 22 of its ownK122853 Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013
Descendant · 2 generations on · 21 of its ownK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

2012high 7 (2022) · low 1 (2012)2026

Most influential descendants

Showing 5 of 53 · See all

K120578Accolade II Hip StemHowmedica Osteonics · 2012 · cites it directly46descendants
K123604Abg Iii Monolithic Hip StemHowmedica Osteonics Corp. · 2013 · cites it directly30descendants
K122853Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013 · cites it directly22descendants
K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics · 2015 · 2 generations on21descendants
K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K921308	HG Multilock Hip Prosthesis W/ TI-Nidium	Zimmer, Inc.	1994	1
−3	K972893	Partnership Revision Femoral Stems	Howmedica Corp.	1997	—
−2	K983404	Type 3 Femoral Components	Howmedica Corp.	1998	1
−1	K013106	2 Piece Modular Hip Stem	Howmedica Osteonics Corp.	2002	37
0 (this device)	K103479	Novel Tapered Hip Stem	Stryker Corp.	2011	—
+1	K120578	Accolade II Hip Stem	Howmedica Osteonics	2012	1
+1	K123604	Abg Iii Monolithic Hip Stem	Howmedica Osteonics Corp.	2013	1
+1	K122853	Novel Fit and Fill Stem	Howmedica Osteonics Corp.	2013	—
+2	K143085	Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…	Stryker Orthopaedics	2015	2
+1	K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0
1995	4	0
1996	3	0
1997	1	0
2000	2	0
2002	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	2	0
2014	2	0
2015	2	0
2016	4	0
2017	5	0
2018	3	0
2019	6	0
2020	3	0
2021	3	0
2022	7	0
2023	5	0
2024	3	0
2025	6	0
2026	1	0

FIG. 1 — Lineage of K103479, 1994–2026Source: 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 MEH? 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 MEH device

#1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 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? (4)

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
*	K994366	TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem Summary page 1 …430 Phone: (201) 831-6461 Fax: (201) 831-3461 Date Prepared: March 9, 2011 Legally Marketed Device to Which Substantial Equivalence is Claimed: Accolade TMZF Hip Stem: K994366, K020572 & K023102 Restoration Modular Hip Stem: K013106 Description: Howmedica Osteonics is introducing the Accolade Il Femor…	Howmedica Osteonics Corp.	2000	3
*	K020572	Accolade TMZF HA 132 Degree Size 0 Hip Stem Summary page 1 …: (201) 831-6461 Fax: (201) 831-3461 Date Prepared: March 9, 2011 Legally Marketed Device to Which Substantial Equivalence is Claimed: Accolade TMZF Hip Stem: K994366, K020572 & K023102 Restoration Modular Hip Stem: K013106 Description: Howmedica Osteonics is introducing the Accolade Il Femoral Hip St…	Howmedica Osteonics Corp.	2002	11
*	K023102	Accolade TMZF Plus HA 127 Size 0 Hip Stem Summary page 1 …1-6461 Fax: (201) 831-3461 Date Prepared: March 9, 2011 Legally Marketed Device to Which Substantial Equivalence is Claimed: Accolade TMZF Hip Stem: K994366, K020572 & K023102 Restoration Modular Hip Stem: K013106 Description: Howmedica Osteonics is introducing the Accolade Il Femoral Hip Stem, a tape…	Howmedica Osteonics Corp.	2002	13
*	K013106	2 Piece Modular Hip Stem Summary page 1 …ed: March 9, 2011 Legally Marketed Device to Which Substantial Equivalence is Claimed: Accolade TMZF Hip Stem: K994366, K020572 & K023102 Restoration Modular Hip Stem: K013106 Description: Howmedica Osteonics is introducing the Accolade Il Femoral Hip Stem, a tapered non-porous coated femoral stem inte…	Howmedica Osteonics Corp.	2002	37

Also cleared against K994366: 5 other devices →

What descends from it? (53)

See all 53

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

Number	Device	Applicant	Decided	Descendants
K120578	Accolade II Hip Stem	Howmedica Osteonics	2012	46
K123604	Abg Iii Monolithic Hip Stem	Howmedica Osteonics Corp.	2013	30
K122853	Novel Fit and Fill Stem	Howmedica Osteonics Corp.	2013	22
K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	17
K211703	Insignia Hip Stem	Stryker Orthopaedics	2021	7
K182468	Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System	Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics	2019	7
K152084	Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…	Corentec Co., Ltd.	2016	7
K131454	Klassic HD (TM) Extended Offset Femoral Head	Total Joint Orthopedics, Inc.	2014	2
K163585	Responsive Orthopedics Total Hip Arthroplasty System	Responsive Orthopedics, LLC	2017	1
K173380	b-ONE® Total Hip System	B-One Ortho, Corp.	2018	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 17 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
11 of the 18 ancestors have a recall of any class.
Of its descendants, K120578 (Howmedica Osteonics, 2012) has gone furthest, with 46 descendants of its own.
5 other devices also cite its predicate K994366.

How does its category compare?

All MEH devices

MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MEH

5in 2025

2007high 6 (2008) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEH

87in 2025

2007high 226 (2010) · low 65 (2009)2026

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

Recalls per year · MEH

1in 2025

2007high 80 (2008) · low 0 (2013)2026

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

Adverse event reports per year · MEH

470in 2025

2007high 1,606 (2012) · low 25 (2007)2025

MAUDE reports naming product code MEH, 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	2	—	3	25
2008	6	79	80	261
2009	6	65	51	539
2010	5	226	16	462
2011	5	95	4	419
2012	6	131	3	1,606
2013	1	—	0	1,295
2014	0	—	1	1,196
2015	2	—	1	490
2016	6	163	4	347
2017	3	209	1	383
2018	2	—	3	337
2019	1	—	0	335
2020	3	131	1	338
2021	3	83	0	372
2022	3	150	0	316
2023	2	—	0	334
2024	6	91	0	354
2025	5	87	1	470
2026	1	—	1	—

What is it indicated for?

The indications for use of the total hip replacement prostheses include: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis - 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and, 5) Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.…

Read the full statement (143 words)

The indications for use of the total hip replacement prostheses include:

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

2) Rheumatoid arthritis -

3) Correction of functional deformity;

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

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

Additional indication specific to use of Accolade 11 Femoral Stems with compatible Howmedica Osteonics Constrained Liners:

1. When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip distocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.

Accolade Il Femoral Stems are intended ft;r cementless use only and are intended for total and hemiarthroplasty procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K103479 · printed Nov 5, 2026

Cite this page

510(k) Report. “K103479: Novel Tapered 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/K103479

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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